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510(k) K053562

ZIMMER COLLAGEN REPAIR PATCH by Tissue Science Laboratories, Plc — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2006
Date Received
December 21, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Tissue Science Laboratories, Plc

  • 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)
  • K992556 — PERMACOL (February 17, 2000)

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