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FDA 510(k)

LYOFOAM WOUND DRESSINGS

K-Number: K860085 · 1986-06-27

ApplicantAcme United Corp.
Decision Date1986-06-27
Product CodeNAD
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

LYOFOAM WOUND DRESSINGS 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 1986-06-27 under 510(k) number K860085. The device is classified under product code NAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the LYOFOAM WOUND DRESSINGS?

LYOFOAM WOUND DRESSINGS is a medical device that received FDA 510(k) clearance on 1986-06-27. The listed applicant is Acme United Corp.. The 510(k) number is K860085.

When did LYOFOAM WOUND DRESSINGS receive FDA 510(k) clearance?

LYOFOAM WOUND DRESSINGS received FDA 510(k) clearance on 1986-06-27, under 510(k) number K860085.

Who is the listed applicant for LYOFOAM WOUND DRESSINGS?

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 WOUND DRESSINGS?

The FDA product code for LYOFOAM WOUND DRESSINGS is NAD.

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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 DRESSINGK952565LYOFOAM EXTRAK895764MODIFIED LYOFOAM WOUND DRESSINGSK871740LYOSHEET SURGICAL SHEET FOR BURNSK864084LYOFOAM C ODOR-ABSORBING DRESSING

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Related Devices (Code: NAD)

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.

K254246LT Antibacterial Foam with Silver DressingZhejiang Longterm Medical Technology Co., Ltd.K102403SAM CHEST SEAL WITH VAVLE; SAM CHEST SEALSam Medical ProductsK091133APLION TOPICAL CARE SYSTEMAplion Medical,LlcK072560ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)Teikoku Pharma USA, Inc.K080524CENTURION SORBAVIEW OTCTri-State Hospital Supply Corp.K060046DERMASTREAMEnzysurge , Ltd.

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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