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FDA 510(k)

ACTICOAT 7 DRESSING

K-Number: K001519 · 2000-10-06

ApplicantWestaim Biomedical, Inc.
Decision Date2000-10-06
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

ACTICOAT 7 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 2000-10-06 under 510(k) number K001519. 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 7 DRESSING?

ACTICOAT 7 DRESSING is a medical device that received FDA 510(k) clearance on 2000-10-06. The listed applicant is Westaim Biomedical, Inc.. The 510(k) number is K001519.

When did ACTICOAT 7 DRESSING receive FDA 510(k) clearance?

ACTICOAT 7 DRESSING received FDA 510(k) clearance on 2000-10-06, under 510(k) number K001519.

Who is the listed applicant for ACTICOAT 7 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 7 DRESSING?

The FDA product code for ACTICOAT 7 DRESSING is FRO. This falls under the Anesthesiology category.

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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.

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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 DRESSINGK992221ACTICOAT PRIMARY ANTIMICROBIAL 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

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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