FDA 510(k)

ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING

K-Number: K091354 · 2009-10-21

Decision Date2009-10-21

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Acrymed, Inc.. It received FDA 510(k) clearance on 2009-10-21 under 510(k) number K091354. 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 ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING?

ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING is a medical device that received FDA 510(k) clearance on 2009-10-21. The listed applicant is Acrymed, Inc.. The 510(k) number is K091354.

When did ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING receive FDA 510(k) clearance?

ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING received FDA 510(k) clearance on 2009-10-21, under 510(k) number K091354.

Who is the listed applicant for ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING?

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

What is the FDA product code for ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING?

The FDA product code for ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING is FRO. This falls under the Anesthesiology category.

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Other records listing Acrymed, Inc. as applicant

K083103ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B K082459ACRYDERM ABSORBENT OXYGEN DRESSING K070333ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL K061232ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006 K011994ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101 K012116ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING

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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.