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FDA 510(k)

LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING

K-Number: K961452 · 1996-05-31

ApplicantAcme United Corp.
Decision Date1996-05-31
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING 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 1996-05-31 under 510(k) number K961452. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING?

LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING is a medical device that received FDA 510(k) clearance on 1996-05-31. The listed applicant is Acme United Corp.. The 510(k) number is K961452.

When did LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING receive FDA 510(k) clearance?

LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING received FDA 510(k) clearance on 1996-05-31, under 510(k) number K961452.

Who is the listed applicant for LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING?

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 LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING?

The FDA product code for LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING is KMF.

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Other records listing Acme United Corp. 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.

K961323LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSINGK952565LYOFOAM EXTRAK895764MODIFIED LYOFOAM WOUND DRESSINGSK871740LYOSHEET SURGICAL SHEET FOR BURNSK864084LYOFOAM C ODOR-ABSORBING DRESSINGK860085LYOFOAM WOUND DRESSINGS

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Related Devices (Code: KMF)

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.

K241916TearRepair Liquid Skin ProtectantOptmed, Inc.K182733Rochal Bioshield Silicone FilmRochal Industries, LLCK171148Aleo BME Liquid BandageAleo Bme, Inc.K153571Cavilon Advanced High Endurance Skin Protectant3M HealthcareK160684Atteris No-Sting Skin ProtectantRochal Industries, LLCK120059LIQUID BANDAGEChesson Laboratory Associates, Inc.

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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