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FDA 510(k)

ACTICOAT PRIMARY ANTIMICROBIAL DRESSING

K-Number: K992221 · 2000-06-07

ApplicantWestaim Biomedical, Inc.
Decision Date2000-06-07
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

ACTICOAT PRIMARY ANTIMICROBIAL DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Westaim Biomedical, Inc.. It received FDA 510(k) clearance on 2000-06-07 under 510(k) number K992221. 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.

Frequently Asked Questions

What is the ACTICOAT PRIMARY ANTIMICROBIAL DRESSING?

ACTICOAT PRIMARY ANTIMICROBIAL DRESSING is a medical device that received FDA 510(k) clearance on 2000-06-07. The listed applicant is Westaim Biomedical, Inc.. The 510(k) number is K992221.

When did ACTICOAT PRIMARY ANTIMICROBIAL DRESSING receive FDA 510(k) clearance?

ACTICOAT PRIMARY ANTIMICROBIAL DRESSING received FDA 510(k) clearance on 2000-06-07, under 510(k) number K992221.

Who is the listed applicant for ACTICOAT PRIMARY ANTIMICROBIAL DRESSING?

The FDA 510(k) record lists Westaim Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACTICOAT PRIMARY ANTIMICROBIAL DRESSING?

The FDA product code for ACTICOAT PRIMARY ANTIMICROBIAL DRESSING is FRO. This falls under the Anesthesiology category.

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Other records listing Westaim Biomedical, Inc. 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.

K010447MODIFICATION TO ACTICOAT FOAM DRESSINGK002466ACTICOAT COMPOSITE DRESSINGK001519ACTICOAT 7 DRESSINGK000051ACTICOAT FOAM DRESSINGK983833ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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