FDA 510(k), K112423, COLLAGEN TENDON SHEET

510(K) Number: K112423
Device Name: COLLAGEN TENDON SHEET
Manufacturer: JEFF SIMS
Device Classification Name: Mesh, Surgical
Regulation Number: FTM
Classification Product Code: KXA
Date Received: 08/23/2011
Decision Date: 12/22/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery

475 pages
348 fully redacted
127 content pages