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510(k) K791885

I.V. START SET by Ascep, Inc. — Product Code KGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1979
Date Received
September 11, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tape And Bandage, Adhesive
Device Class
Class I
Regulation Number
880.5240
Review Panel
SU
Submission Type

Other clearances by Ascep, Inc.

  • K830219 — VARIOUS INSTRUMENTS & INSTRUMENT TRAYS (April 12, 1983)
  • K822893 — G.E.V. DISPOSABLE SCALPELS (October 22, 1982)
  • K810004 — STERILE DISPOSABLE INSTRUMENT TRAYS (January 26, 1981)
  • K802726 — INSTRUMENTS NONSTERILE & STERILE (November 19, 1980)
  • K791886 — I.V. CARE KIT (October 26, 1979)
  • K791888 — CATHETER CARE KIT REORDER 7940&7941 (October 17, 1979)
  • K791889 — SUTURE REMOVAL TRAY, REORDER 7950&7951 (October 17, 1979)
  • K791887 — CENTRAL VENOUS CATHETER DRESSING TRAY (October 17, 1979)

Other clearances for product code KGX

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  • K983368 — CARE BAND ANTIBACTERIAL BANDAGES (February 17, 1999)
  • K972914 — SYVEK PATCH (December 22, 1997)
  • K943314 — ADHESIVE BANDAGES WITH OTC DRUG (January 17, 1996)
  • K952606 — TARGETT PATCH (December 21, 1995)
  • K954007 — PARALLEL (November 22, 1995)
  • K944587 — DERMIVIEW HYPOALLERGENIC CLEAR TAPE (October 30, 1995)
  • K944588 — STERILE PLASTIC DRESSING (November 7, 1994)
  • K941788 — BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP (October 3, 1994)
  • K940536 — BAND-AID(TM) BRAND ADHESIVE BANDAGE (October 3, 1994)