FDA 510(k)

ALLEVYN AG DRESSING

K-Number: K063835 · 2007-08-03

Decision Date2007-08-03

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

ALLEVYN AG DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2007-08-03 under 510(k) number K063835. 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 ALLEVYN AG DRESSING?

ALLEVYN AG DRESSING is a medical device that received FDA 510(k) clearance on 2007-08-03. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K063835.

When did ALLEVYN AG DRESSING receive FDA 510(k) clearance?

ALLEVYN AG DRESSING received FDA 510(k) clearance on 2007-08-03, under 510(k) number K063835.

Who is the listed applicant for ALLEVYN AG DRESSING?

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

What is the FDA product code for ALLEVYN AG DRESSING?

The FDA product code for ALLEVYN AG DRESSING is FRO. This falls under the Anesthesiology category.

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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.