BURN SHEET— 510(k) K926290

Substantially Equivalent

Gam Industries, Inc.

FDA 510(k) clearance K926290 for BURN SHEET, Substantially Equivalent on 1993-04-20. Applicant: Gam Industries, Inc.. Device class: 1.

Clearance details

Applicant: Gam Industries, Inc.
Product code: Code FPY
Device class: Class 1
Regulation: 21 CFR 880.5180
Advisory panel: General Hospital
Date received: 1992-12-14
Decision date: 1993-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Petersburg, VA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FPY

K930759 — CP & S STERILE BURN SHEET1994-01-21
K921470 — BURNSHIELD FIRE BLANKET1993-04-20
K921471 — BURNSHIELD TRAUMA DRESSING1993-04-20
K900441 — BURNS CASUALTY SHEET1990-07-03
K900442 — BURNS CASUALTY SHEET BURN ROLL1990-07-03

More clearances from Gam Industries, Inc.

K941641 — DISPOSABLE EMERGENCY OBSTETRICAL KIT1994-10-03
K941336 — COMBO MASK1994-09-09
K942021 — MOUTH TO MOUTH BREATHER1994-06-22
K936050 — JAW SPREADER1994-03-24
K930401 — ALUMINUM FOIL1993-05-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.