• FDA DYMISTA NDA 202236 approval records — 22 FDA documents, 848 pages
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FDA 510(k) K855121, COLOSHIELD KIT, by Deknatel, Inc.

FDA 510(k) K855121, COLOSHIELD KIT, by Deknatel, Inc.

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510(K) Number: K855121
Device Name: COLOSHIELD KIT
Manufacturer: Deknatel, Inc.
Device Classification Name: tubes, gastrointestinal (and accessories)
Regulation Number: 876.5980
Classification Product Code: KNT
Date Received: 12/23/1985
Decision Date: 01/08/1986
Regulation Medical Specialty: Gastroenterology/Urology

Total pages: 51
Fully redacted pages: 21
Content pages: 30
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