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FDA 510(k)

LYOFOAM C ODOR-ABSORBING DRESSING

K-Number: K864084 · 1986-11-21

ApplicantAcme United Corp.
Decision Date1986-11-21
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

LYOFOAM C ODOR-ABSORBING 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 1986-11-21 under 510(k) number K864084. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the LYOFOAM C ODOR-ABSORBING DRESSING?

LYOFOAM C ODOR-ABSORBING DRESSING is a medical device that received FDA 510(k) clearance on 1986-11-21. The listed applicant is Acme United Corp.. The 510(k) number is K864084.

When did LYOFOAM C ODOR-ABSORBING DRESSING receive FDA 510(k) clearance?

LYOFOAM C ODOR-ABSORBING DRESSING received FDA 510(k) clearance on 1986-11-21, under 510(k) number K864084.

Who is the listed applicant for LYOFOAM C ODOR-ABSORBING 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 C ODOR-ABSORBING DRESSING?

The FDA product code for LYOFOAM C ODOR-ABSORBING DRESSING is FRO. This falls under the Anesthesiology category.

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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 BURNSK860085LYOFOAM WOUND DRESSINGS

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Related Devices (Code: FRO)

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.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, 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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