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510(k) K926448

I.V. ADMINISTRATION SET by Gainor Medical Europe, Ltd. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1994
Date Received
December 23, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Gainor Medical Europe, Ltd.

  • K931828 — CARELET SAFETY LANCET (October 15, 1993)
  • K931827 — CLEANLET, CLEANLET XL & KIDS (September 13, 1993)
  • K922441 — SURESEAL BANDAGE (August 10, 1993)
  • K913333 — I.V. PRIMING SET (October 23, 1991)
  • K902422 — NEEDLE, ASPIRATION & INJECTION, DISPOSABLE (June 6, 1991)
  • K902420 — CATHETER, NASAL, OXYGEN (April 17, 1991)
  • K902564 — NEEDLE, DIALYSIS (March 1, 1991)
  • K902421 — STOMACH, GASTRO-ENTEROSTOMY (November 20, 1990)
  • K902426 — HEMODIALYSIS SYSTEM AND ACCESSORY (November 20, 1990)
  • K902416 — SURELITE AND SURELITE XL BLOOD LANCET (August 1, 1990)

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