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510(k) K792433

TEMPORARY BURN SHEET WITH PERFORATED by American Medical Disposable, Inc. — Product Code FPY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1979
Date Received
November 28, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sheet, Burn
Device Class
Class I
Regulation Number
880.5180
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)
  • K833731 — BREATHABLE OVERWRAY BANDAGE NON-ELAS (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)
  • K830202 — COTTON BALLS, X-RAY OPAQUED STRUNG & NON (February 23, 1983)
  • K830201 — POLYESTER X-RAY DETECTABLE STRUNG-SPONGE (February 23, 1983)
  • K803116 — HEAVY DRAINAGE PACK (January 28, 1981)

Other clearances for product code FPY

  • K930759 — CP & S STERILE BURN SHEET (January 21, 1994)
  • K921471 — BURNSHIELD TRAUMA DRESSING (April 20, 1993)
  • K921470 — BURNSHIELD FIRE BLANKET (April 20, 1993)
  • K926290 — BURN SHEET (April 20, 1993)
  • K900443 — BURNS CASUALTY SHEET LIMB WRAP (July 3, 1990)
  • K900441 — BURNS CASUALTY SHEET (July 3, 1990)
  • K900442 — BURNS CASUALTY SHEET BURN ROLL (July 3, 1990)
  • K871740 — LYOSHEET SURGICAL SHEET FOR BURNS (June 9, 1987)
  • K853145 — KENDALL CURITY BURN PAD (August 30, 1985)
  • K841898 — FIRST RESPONSE EMERG. MEDICSL - BURNS (August 14, 1984)