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FDA 510(k)

ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B

K-Number: K083103 · 2009-02-26

ApplicantAcrymed, Inc.
Decision Date2009-02-26
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B is the device name listed in this FDA 510(k) record. The listed applicant is Acrymed, Inc.. It received FDA 510(k) clearance on 2009-02-26 under 510(k) number K083103. 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 ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B?

ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B is a medical device that received FDA 510(k) clearance on 2009-02-26. The listed applicant is Acrymed, Inc.. The 510(k) number is K083103.

When did ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B receive FDA 510(k) clearance?

ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B received FDA 510(k) clearance on 2009-02-26, under 510(k) number K083103.

Who is the listed applicant for ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B?

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 ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B?

The FDA product code for ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B is FRO. This falls under the Anesthesiology category.

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Other records listing Acrymed, Inc. 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.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.

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.

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