• FDA DYMISTA NDA 202236 approval records — 22 FDA documents, 848 pages
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FDA 510(k) K922186, HEM-O-LOK -- MODIFICATION, by Linvatec Corp.

FDA 510(k) K922186, HEM-O-LOK -- MODIFICATION, by Linvatec Corp.

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510(K) Number: K922186
Device Name: HEM-O-LOK -- MODIFICATION
Manufacturer: Linvatec Corp.
Device Classification Name: staple, implantable
Regulation Number: 878.4750
Classification Product Code: GDW
Date Received: 02/27/1992
Decision Date: 08/06/1992
Regulation Medical Specialty: General & Plastic Surgery
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