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FDA 510(k)

BURN SHEET

K-Number: K926290 · 1993-04-20

ApplicantGam Industries, Inc.
Decision Date1993-04-20
Product CodeFPY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BURN SHEET is the device name listed in this FDA 510(k) record. The listed applicant is Gam Industries, Inc.. It received FDA 510(k) clearance on 1993-04-20 under 510(k) number K926290. The device is classified under product code FPY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BURN SHEET?

BURN SHEET is a medical device that received FDA 510(k) clearance on 1993-04-20. The listed applicant is Gam Industries, Inc.. The 510(k) number is K926290.

When did BURN SHEET receive FDA 510(k) clearance?

BURN SHEET received FDA 510(k) clearance on 1993-04-20, under 510(k) number K926290.

Who is the listed applicant for BURN SHEET?

The FDA 510(k) record lists Gam Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BURN SHEET?

The FDA product code for BURN SHEET is FPY.

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Other records listing Gam Industries, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K941641DISPOSABLE EMERGENCY OBSTETRICAL KITK941336COMBO MASKK942021MOUTH TO MOUTH BREATHERK936050JAW SPREADERK930401ALUMINUM FOILK925590MULTI-TRAUMA DRESSING

View all 9 devices →

Related Devices (Code: FPY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K930759CP & S STERILE BURN SHEETConsolidated Products & Services, Inc.K921471BURNSHIELD TRAUMA DRESSINGLevtrade Intl. (Pty) , Ltd.K921470BURNSHIELD FIRE BLANKETLevtrade Intl. (Pty) , Ltd.K900442BURNS CASUALTY SHEET BURN ROLLPilgrim Medical ServicesK900443BURNS CASUALTY SHEET LIMB WRAPPilgrim Medical ServicesK900441BURNS CASUALTY SHEETPilgrim Medical Services

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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