FDA 510(k)

TEMPORARY BURN SHEET WITH PERFORATED

K-Number: K792433 · 1979-12-20

ApplicantAmerican Medical Disposable, Inc.

Decision Date1979-12-20

Product CodeFPY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

TEMPORARY BURN SHEET WITH PERFORATED is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Disposable, Inc.. It received FDA 510(k) clearance on 1979-12-20 under 510(k) number K792433. 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 TEMPORARY BURN SHEET WITH PERFORATED?

TEMPORARY BURN SHEET WITH PERFORATED is a medical device that received FDA 510(k) clearance on 1979-12-20. The listed applicant is American Medical Disposable, Inc.. The 510(k) number is K792433.

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

TEMPORARY BURN SHEET WITH PERFORATED received FDA 510(k) clearance on 1979-12-20, under 510(k) number K792433.

Who is the listed applicant for TEMPORARY BURN SHEET WITH PERFORATED?

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

What is the FDA product code for TEMPORARY BURN SHEET WITH PERFORATED?

The FDA product code for TEMPORARY BURN SHEET WITH PERFORATED is FPY.

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Other records listing American Medical Disposable, Inc. as applicant

K833734NEUROLOGICAL SPONGE ON PLASTIC STICK K833735AN ODOR ABSORBENT BANDAGE K833730NON ADHERENT BANDAGE/SHEET K833731BREATHABLE OVERWRAY BANDAGE NON-ELAS K833729ELASTIC BREATHABLE OVER-WRAP BANDAGE K833733NON - ADHERENT BANDAGE

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Related Devices (Code: FPY)

K930759CP & S STERILE BURN SHEETConsolidated Products & Services, Inc.K921470BURNSHIELD FIRE BLANKETLevtrade Intl. (Pty) , Ltd.K921471BURNSHIELD TRAUMA DRESSINGLevtrade Intl. (Pty) , Ltd.K926290BURN SHEETGam Industries, Inc.K900441BURNS CASUALTY SHEETPilgrim Medical Services K900442BURNS CASUALTY SHEET BURN ROLLPilgrim 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.