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510(k) K871740

LYOSHEET SURGICAL SHEET FOR BURNS by Acme United Corp. — Product Code FPY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1987
Date Received
May 5, 1987
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

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  • K842186 — ACU-DERM TRANSPARENT WOUND DRESSING (August 24, 1984)
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Other clearances for product code FPY

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  • 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)
  • K853145 — KENDALL CURITY BURN PAD (August 30, 1985)
  • K841898 — FIRST RESPONSE EMERG. MEDICSL - BURNS (August 14, 1984)
  • K820994 — ABSORB FURN SHEET (May 13, 1982)