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FDA 510(k)

ACTICOAT FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSING

K-Number: K002896 · 2001-02-21

ApplicantThe Westaim Corp.
Decision Date2001-02-21
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

ACTICOAT FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is The Westaim Corp.. It received FDA 510(k) clearance on 2001-02-21 under 510(k) number K002896. 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 FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSING?

ACTICOAT FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSING is a medical device that received FDA 510(k) clearance on 2001-02-21. The listed applicant is The Westaim Corp.. The 510(k) number is K002896.

When did ACTICOAT FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSING receive FDA 510(k) clearance?

ACTICOAT FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSING received FDA 510(k) clearance on 2001-02-21, under 510(k) number K002896.

Who is the listed applicant for ACTICOAT FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSING?

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

What is the FDA product code for ACTICOAT FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSING?

The FDA product code for ACTICOAT FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSING is FRO. This falls under the Anesthesiology category.

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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.

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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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