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FDA 510(k)

ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL

K-Number: K092826 · 2009-11-12

ApplicantAmerican Biotech Labs
Decision Date2009-11-12
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL is the device name listed in this FDA 510(k) record. The listed applicant is American Biotech Labs. It received FDA 510(k) clearance on 2009-11-12 under 510(k) number K092826. 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 ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL?

ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL is a medical device that received FDA 510(k) clearance on 2009-11-12. The listed applicant is American Biotech Labs. The 510(k) number is K092826.

When did ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL receive FDA 510(k) clearance?

ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL received FDA 510(k) clearance on 2009-11-12, under 510(k) number K092826.

Who is the listed applicant for ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL?

The FDA 510(k) record lists American Biotech Labs as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL?

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

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Other records listing American Biotech Labs 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.

K082333ASAP WOUND DRESSING GEL

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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