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510(k) K992556

PERMACOL by Tissue Science Laboratories, Plc — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2000
Date Received
July 30, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Polymeric
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

Other clearances by Tissue Science Laboratories, Plc

  • K053562 — ZIMMER COLLAGEN REPAIR PATCH (June 23, 2006)
  • K050355 — PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MO (March 9, 2005)
  • K043366 — PERMACOL SURGICAL IMPLANT (December 17, 2004)
  • K021056 — PERMACOL (October 31, 2002)
  • K013625 — PERMACOL (January 17, 2002)

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