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510(k) K833731

BREATHABLE OVERWRAY BANDAGE NON-ELAS by American Medical Disposable, Inc. — Product Code KGX

K833731 is an FDA 510(k) premarket notification submitted by American Medical Disposable, Inc. for the device "BREATHABLE OVERWRAY BANDAGE NON-ELAS". The FDA issued a decision of Substantially Equivalent on January 27, 1984. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. American Medical Disposable, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1984
Date Received
October 25, 1983
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 American Medical Disposable, Inc.

  • K833734 — NEUROLOGICAL SPONGE ON PLASTIC STICK (April 23, 1984)
  • K833735 — AN ODOR ABSORBENT BANDAGE (April 23, 1984)
  • K833730 — NON ADHERENT BANDAGE/SHEET (January 27, 1984)
  • K833729 — ELASTIC BREATHABLE OVER-WRAP BANDAGE (December 30, 1983)
  • K833733 — NON - ADHERENT BANDAGE (December 27, 1983)
  • K833732 — NON WETTING UNDERCAST PADDING (December 12, 1983)
  • K830201 — POLYESTER X-RAY DETECTABLE STRUNG-SPONGE (February 23, 1983)
  • K830202 — COTTON BALLS, X-RAY OPAQUED STRUNG & NON (February 23, 1983)
  • K803116 — HEAVY DRAINAGE PACK (January 28, 1981)
  • K803115 — DRESSING CHANGE FOR G TUBE (January 6, 1981)

Other clearances for product code KGX

  • K001240 — SERAGARD INJECTION PATCH (June 21, 2000)
  • 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)

FDA data resources