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

CCSI 22.03

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9:52 AM EST

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To: Solarity who wrote (19)	5/7/1997 9:06:00 AM
From: Fred Puppet	of 5736

Erik, how can you be so sure that the FDA request is benign? The press release stated: "The company believes it will be the able to respond to the FDA within the required 30-day period; however, if the company is not able to do so, it will be required to either request an extension or refile the 510(k) submission." I read this as the FDA saying get the information, get it quick, or get lost. Routine requests don't have 30 day deadlines. A slow response to routine requests doesn't get the entire application rejected.

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