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510(k) K926290

BURN SHEET by Gam Industries, Inc. — Product Code FPY

K926290 is an FDA 510(k) premarket notification submitted by Gam Industries, Inc. for the device "BURN SHEET". The FDA issued a decision of Substantially Equivalent on April 20, 1993. The device falls under product code FPY (Sheet, Burn), a Class I device regulated under 21 CFR 880.5180. Gam Industries, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1993
Date Received
December 14, 1992
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 Gam Industries, Inc.

  • K941641 — DISPOSABLE EMERGENCY OBSTETRICAL KIT (October 3, 1994)
  • K941336 — COMBO MASK (September 9, 1994)
  • K942021 — MOUTH TO MOUTH BREATHER (June 22, 1994)
  • K936050 — JAW SPREADER (March 24, 1994)
  • K930401 — ALUMINUM FOIL (May 12, 1993)
  • K925590 — MULTI-TRAUMA DRESSING (April 8, 1993)
  • K915569 — UMBILICAL CLAMP (September 23, 1992)
  • K915303 — FOIL BABY BUNTING (February 20, 1992)

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)
  • 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)
  • K820994 — ABSORB FURN SHEET (May 13, 1982)

FDA data resources