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510(k) K871740

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

K871740 is an FDA 510(k) premarket notification submitted by Acme United Corp. for the device "LYOSHEET SURGICAL SHEET FOR BURNS". The FDA issued a decision of Substantially Equivalent on June 9, 1987. The device falls under product code FPY (Sheet, Burn), a Class I device regulated under 21 CFR 880.5180. Acme United Corp. has at least 10 other 510(k) clearances on record.

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

Other clearances by Acme United Corp.

  • K961323 — LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING (June 19, 1996)
  • K961452 — LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING (May 31, 1996)
  • K952565 — LYOFOAM EXTRA (November 14, 1995)
  • K895764 — MODIFIED LYOFOAM WOUND DRESSINGS (September 10, 1990)
  • K864084 — LYOFOAM C ODOR-ABSORBING DRESSING (November 21, 1986)
  • K860085 — LYOFOAM WOUND DRESSINGS (June 27, 1986)
  • K860818 — ONE TIME ENTERAL FEEDING BAG (May 15, 1986)
  • K861015 — ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS (April 22, 1986)
  • K842186 — ACU-DERM TRANSPARENT WOUND DRESSING (August 24, 1984)
  • K842064 — ACU-DERM TRANSPARENT IV DRESSING (August 15, 1984)

Other clearances for product code FPY

  • K930759 — CP & S STERILE BURN SHEET (January 21, 1994)
  • K926290 — BURN SHEET (April 20, 1993)
  • K921470 — BURNSHIELD FIRE BLANKET (April 20, 1993)
  • K921471 — BURNSHIELD TRAUMA DRESSING (April 20, 1993)
  • K900441 — BURNS CASUALTY SHEET (July 3, 1990)
  • K900443 — BURNS CASUALTY SHEET LIMB WRAP (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)

FDA data resources