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FDA 510(k)

ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL

K-Number: K070333 · 2007-07-10

ApplicantAcrymed, Inc.
Decision Date2007-07-10
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL is the device name listed in this FDA 510(k) record. The listed applicant is Acrymed, Inc.. It received FDA 510(k) clearance on 2007-07-10 under 510(k) number K070333. 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 OTC WOUND GEL?

ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL is a medical device that received FDA 510(k) clearance on 2007-07-10. The listed applicant is Acrymed, Inc.. The 510(k) number is K070333.

When did ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL receive FDA 510(k) clearance?

ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL received FDA 510(k) clearance on 2007-07-10, under 510(k) number K070333.

Who is the listed applicant for ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL?

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 OTC WOUND GEL?

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

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Other records listing Acrymed, Inc. as applicant

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.

K091354ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSINGK083103ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #BK082459ACRYDERM ABSORBENT OXYGEN DRESSINGK061232ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006K011994ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101K012116ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING

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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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