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FDA 510(k)

COPA AMD ANTIMICROBIAL WOUND DRESSING

K-Number: K071371 · 2007-11-19

ApplicantTyco Healthcare Group LP
Decision Date2007-11-19
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

COPA AMD ANTIMICROBIAL WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Tyco Healthcare Group LP. It received FDA 510(k) clearance on 2007-11-19 under 510(k) number K071371. 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 COPA AMD ANTIMICROBIAL WOUND DRESSING?

COPA AMD ANTIMICROBIAL WOUND DRESSING is a medical device that received FDA 510(k) clearance on 2007-11-19. The listed applicant is Tyco Healthcare Group LP. The 510(k) number is K071371.

When did COPA AMD ANTIMICROBIAL WOUND DRESSING receive FDA 510(k) clearance?

COPA AMD ANTIMICROBIAL WOUND DRESSING received FDA 510(k) clearance on 2007-11-19, under 510(k) number K071371.

Who is the listed applicant for COPA AMD ANTIMICROBIAL WOUND DRESSING?

The FDA 510(k) record lists Tyco Healthcare Group LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COPA AMD ANTIMICROBIAL WOUND DRESSING?

The FDA product code for COPA AMD ANTIMICROBIAL WOUND DRESSING is FRO. This falls under the Anesthesiology category.

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Other records listing Tyco Healthcare Group LP as applicant

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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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