Chromatics Color Sciences International. Inc; CCSI Message Board

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Biotech / Medical : Chromatics Color Sciences International. Inc; CCSI

CCSI 29.32

+4.6%

Oct 31 9:30 AM EDT

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To: Eric Anderson who wrote (3267)	6/18/1998 3:06:00 PM
From: Gurupup	Read Replies (1) of 5736

\| Next \| Respond \| Show Navigation To: +Skipard (3236 ) From: +Eric Anderson Thursday, Jun 18 1998 2:21PM ET Reply # of 3269 Skip: With the new handheld device that CCSI has now developed, do they have to get FDA approval of this new device as equilvalent to the one that was approved last summer. ANSWER: The device operates as a battery-powered hand-held instrument, or as a portable briefcase unit using an external power scource, with a battery backup. I haven't read anything that directly says so, but in the CCSI rebuttal, there is a statement that CCSI is going through so type of regulatory approval of the revised device. Answer. CCSI is developing a LED unit which will reuqire an amendment to their application. But, they are marketing the new hand-held device which I described above, which is FDA approved. Long on ccsi for 2+ yrs.

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