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FDA 510(k)

LYOSHEET SURGICAL SHEET FOR BURNS

K-Number: K871740 · 1987-06-09

ApplicantAcme United Corp.
Decision Date1987-06-09
Product CodeFPY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LYOSHEET SURGICAL SHEET FOR BURNS is the device name listed in this FDA 510(k) record. The listed applicant is Acme United Corp.. It received FDA 510(k) clearance on 1987-06-09 under 510(k) number K871740. 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 LYOSHEET SURGICAL SHEET FOR BURNS?

LYOSHEET SURGICAL SHEET FOR BURNS is a medical device that received FDA 510(k) clearance on 1987-06-09. The listed applicant is Acme United Corp.. The 510(k) number is K871740.

When did LYOSHEET SURGICAL SHEET FOR BURNS receive FDA 510(k) clearance?

LYOSHEET SURGICAL SHEET FOR BURNS received FDA 510(k) clearance on 1987-06-09, under 510(k) number K871740.

Who is the listed applicant for LYOSHEET SURGICAL SHEET FOR BURNS?

The FDA 510(k) record lists Acme United Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LYOSHEET SURGICAL SHEET FOR BURNS?

The FDA product code for LYOSHEET SURGICAL SHEET FOR BURNS is FPY.

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Other records listing Acme United Corp. as applicant

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K961323LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSINGK961452LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSINGK952565LYOFOAM EXTRAK895764MODIFIED LYOFOAM WOUND DRESSINGSK864084LYOFOAM C ODOR-ABSORBING DRESSINGK860085LYOFOAM WOUND DRESSINGS

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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.K921470BURNSHIELD FIRE BLANKETLevtrade Intl. (Pty) , Ltd.K921471BURNSHIELD TRAUMA DRESSINGLevtrade Intl. (Pty) , Ltd.K926290BURN SHEETGam Industries, Inc.K900441BURNS CASUALTY SHEETPilgrim Medical ServicesK900442BURNS 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.

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