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510(k) K912111

MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTE by Gerard Medical Enterprises, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 1991
Date Received
May 13, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by Gerard Medical Enterprises, Inc.

  • K954258 — TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION) (May 24, 1996)
  • K945250 — TRIMPORT (March 7, 1995)
  • K942623 — TRIMPORT (August 23, 1994)
  • K922147 — DUAL PLASTIC VASCULAR ACCESS SYSTEM (December 4, 1992)
  • K913114 — TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT (January 2, 1992)
  • K903364 — GERARD MEDICAL, INC. TRIM-PORT (October 31, 1990)
  • K813358 — GERARD MEDICAL ELECTRODE TESTER (December 29, 1981)

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