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FDA 510(k)

LYOFOAM EXTRA

K-Number: K952565 · 1995-11-14

ApplicantAcme United Corp.
Decision Date1995-11-14
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent for Some Indications

Device Summary

LYOFOAM EXTRA 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 1995-11-14 under 510(k) number K952565. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the LYOFOAM EXTRA?

LYOFOAM EXTRA is a medical device that received FDA 510(k) clearance on 1995-11-14. The listed applicant is Acme United Corp.. The 510(k) number is K952565.

When did LYOFOAM EXTRA receive FDA 510(k) clearance?

LYOFOAM EXTRA received FDA 510(k) clearance on 1995-11-14, under 510(k) number K952565.

Who is the listed applicant for LYOFOAM EXTRA?

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?

The FDA product code for LYOFOAM EXTRA 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 DRESSINGK961452LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSINGK895764MODIFIED LYOFOAM WOUND DRESSINGSK871740LYOSHEET SURGICAL SHEET FOR BURNSK864084LYOFOAM C ODOR-ABSORBING DRESSINGK860085LYOFOAM WOUND DRESSINGS

View all 27 devices →

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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