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510(k) K900441

BURNS CASUALTY SHEET by Pilgrim Medical Services — Product Code FPY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 1990
Date Received
January 30, 1990
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 Pilgrim Medical Services

  • K900443 — BURNS CASUALTY SHEET LIMB WRAP (July 3, 1990)
  • K900442 — BURNS CASUALTY SHEET BURN ROLL (July 3, 1990)

Other clearances for product code FPY

  • K930759 — CP & S STERILE BURN SHEET (January 21, 1994)
  • K921470 — BURNSHIELD FIRE BLANKET (April 20, 1993)
  • K926290 — BURN SHEET (April 20, 1993)
  • K921471 — BURNSHIELD TRAUMA DRESSING (April 20, 1993)
  • K900443 — BURNS CASUALTY SHEET LIMB WRAP (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)
  • K820994 — ABSORB FURN SHEET (May 13, 1982)