FDA 510(k)

ACTICOAT FLEX 7 DRESSING

K-Number: K083113 · 2009-07-22

Decision Date2009-07-22

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

ACTICOAT FLEX 7 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 2009-07-22 under 510(k) number K083113. 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 FLEX 7 DRESSING?

ACTICOAT FLEX 7 DRESSING is a medical device that received FDA 510(k) clearance on 2009-07-22. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K083113.

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

ACTICOAT FLEX 7 DRESSING received FDA 510(k) clearance on 2009-07-22, under 510(k) number K083113.

Who is the listed applicant for ACTICOAT FLEX 7 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 ACTICOAT FLEX 7 DRESSING?

The FDA product code for ACTICOAT FLEX 7 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.