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510(k) K760365

BLANKET, BURN by Winn Hirsch & Assoc. — Product Code FPY

K760365 is an FDA 510(k) premarket notification submitted by Winn Hirsch & Assoc. for the device "BLANKET, BURN". The FDA issued a decision of Substantially Equivalent on August 11, 1976. The device falls under product code FPY (Sheet, Burn), a Class I device regulated under 21 CFR 880.5180. Winn Hirsch & Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1976
Date Received
August 3, 1976
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 Winn Hirsch & Assoc.

  • K880309 — TYPE 316L STAINLESS STEEL WIRE (February 29, 1988)
  • K864375 — TYPE 316L COTTER WIRE (May 20, 1987)
  • K832214 — GAUZE CONVERSION CLASS I-NON-STERILE (July 26, 1983)
  • K832213 — GAUZE CONVERSION CLASS II STERILE (July 26, 1983)
  • K830511 — ZANLEX, ZAN-TEX & ZANDEX (March 17, 1983)
  • K812391 — NEUROSPONGES (November 24, 1981)
  • K812390 — NEUROSPONGE PADDIE (November 24, 1981)
  • K800195 — COTTON UNDER CAST PADDING (February 11, 1980)
  • K761155 — CELLULOSE EYE STICK (December 16, 1976)
  • K760513 — ELECTRODE, TEMPORARY MYOCARDIAL (October 15, 1976)

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)
  • K900442 — BURNS CASUALTY SHEET BURN ROLL (July 3, 1990)
  • K900443 — BURNS CASUALTY SHEET LIMB WRAP (July 3, 1990)
  • K900441 — BURNS CASUALTY SHEET (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)

FDA data resources