Home / 510(k) Clearances / K760210

510(k) K760210

BLANKET, WATER-JEL FIRE by American Safety — Product Code FPY

K760210 is an FDA 510(k) premarket notification submitted by American Safety for the device "BLANKET, WATER-JEL FIRE". 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. American Safety has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1976
Date Received
July 12, 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 American Safety

  • K790195 — FOOT VALVE (February 26, 1979)

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)
  • 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)
  • 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