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510(k) K043366

PERMACOL SURGICAL IMPLANT by Tissue Science Laboratories, Plc — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2004
Date Received
December 8, 2004
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)
  • K021056 — PERMACOL (October 31, 2002)
  • K013625 — PERMACOL (January 17, 2002)
  • K992556 — PERMACOL (February 17, 2000)

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