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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported) May 23, 1997
CHROMATICS COLOR SCIENCES INTERNATIONAL, INC.
(Exact Name of Registrant as Specified in Charter)
New York 0-21168 13-3253392
(State or Other (Commission File (IRS Employer
Jurisdiction of Number) Identification No.)
Incorporation)
5 East 80th Street, New York, New York 10021
(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code (212) 717-6544
(Former Name or Former Address, if Changed Since Last Report)
Page 1 of 5 pages
Exhibit Index located on page 4
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ITEM 5. OTHER EVENTS
On May 23, 1997, Chromatics Color Sciences International, Inc., a New
York corporation (the "Company"), filed its response within the requisite 30-day
period to a request for supplementary information and clarifications from the
U.S. Food and Drug Administration ("FDA") for purposes of the agency's review of
the Company's premarket notification (510(k)) submission regarding its
Colormate(TM) device for the non-invasive monitoring of bilirubin infant
jaundice. No assurance can be given as to whether the FDA will clear the device
for commercial use, or as to the timing of the FDA's review of and response to
the Company's supplemental submission.
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SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of
1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
CHROMATICS COLOR SCIENCES
INTERNATIONAL, INC.
By /s/ Darby S. Macfarlane
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Name: Darby S. Macfarlane
Title: Chief Executive Officer
Date: May 29, 1997
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EXHIBIT INDEX
Exhibit Description Page
99 Chromatics Color Sciences 5
International Inc. Press
Release, dated May 27, 1997
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CHROMATICS COLOR SCIENCES
INTERNATIONAL, INC.
Contact: Darby S. Macfarlane
Telephone: (212) 717-6544
Fax: (212) 717-6675
FOR IMMEDIATE RELEASE
May 27, 1997
On Friday, May 23, 1997, Chromatics Color Sciences International, Inc.
filed its response to an April 25, 1997 request (confirmed by an April 29, 1997
letter) from the Center for Devices and Radiological Health (CDRH), Food and
Drug Administration (FDA), asking for additional information as part of the
agency's review of Chromatics' premarket notification (510(k)) submission
regarding the Company's Colormate(TM) device for non-invasive monitoring of
bilirubin infant jaundice. The Company responded to the FDA request within the
30-day period ending May 29, 1997.
The Company is engaged in the business of color science, including the
scientific color measurement and classification of human skin, certain
color-sensitive consumer products, and in determining the color compatibility of
such skin and product color classification for use in a variety of industries
including the cosmetic, beauty aid and fashion industries, as well as technology
development for potential medical applications involving the detection and
monitoring of certain chromogenic diseases. The Company's common stock and
warrants are traded on NASDAQ under the symbols "CCSI" and "CCSIW" respectively.
Certain of the matters discussed are forward-looking statements that
involve materials risks to and uncertainties in the Company's business which may
cause actual results to differ materially from those anticipated by the
statements made herein. Such risks and uncertainties include, among other
things, the availability of any needed financing, the Company's ability to
implement its long-range business plan for various applications for its
technologies, the impact of competition, the obtaining of and compliance with
regulatory approvals applicable to proposed application of the Company's
technology, management of growth and other risks and uncertainties that may be
detailed from time to time in the Company's reports filed with the Securities
Exchange Commission, including those set forth in its annual report on Form
10-KSB.
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