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510(k) K800064

WATER JEL FIRE BLANKET by Trilling Resources, Ltd. — Product Code FPY

K800064 is an FDA 510(k) premarket notification submitted by Trilling Resources, Ltd. for the device "WATER JEL FIRE BLANKET". The FDA issued a decision of Substantially Equivalent on March 25, 1980. The device falls under product code FPY (Sheet, Burn), a Class I device regulated under 21 CFR 880.5180. Trilling Resources, Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1980
Date Received
January 11, 1980
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 Trilling Resources, Ltd.

  • K864841 — WATER-JEL(R) BURN DRESSING (January 22, 1988)

Other clearances for product code FPY

  • K930759 — CP & S STERILE BURN SHEET (January 21, 1994)
  • K921470 — BURNSHIELD FIRE BLANKET (April 20, 1993)
  • K921471 — BURNSHIELD TRAUMA DRESSING (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