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510(k) K945060

HERNIA MESH INTRODUCTION SYSTEM by Gerard Medical, Inc. — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1995
Date Received
October 14, 1994
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 Gerard Medical, Inc.

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  • K972555 — CATHETER TUNNELER (December 22, 1997)
  • K936207 — ENDO-NEEDLE INSTRUMENT (June 16, 1994)

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