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510(k) K974533

TRIMPORT by Gerard Medical, Inc. — Product Code LJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1998
Date Received
December 2, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class
Class II
Regulation Number
880.5965
Review Panel
HO
Submission Type

Other clearances by Gerard Medical, Inc.

  • K972555 — CATHETER TUNNELER (December 22, 1997)
  • K945060 — HERNIA MESH INTRODUCTION SYSTEM (March 2, 1995)
  • K936207 — ENDO-NEEDLE INSTRUMENT (June 16, 1994)

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