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FDA 510(k)

POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC)

K-Number: K121522 · 2012-06-27

ApplicantPolyremedy, Inc.
Decision Date2012-06-27
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC) is the device name listed in this FDA 510(k) record. The listed applicant is Polyremedy, Inc.. It received FDA 510(k) clearance on 2012-06-27 under 510(k) number K121522. 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 POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC)?

POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC) is a medical device that received FDA 510(k) clearance on 2012-06-27. The listed applicant is Polyremedy, Inc.. The 510(k) number is K121522.

When did POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC) receive FDA 510(k) clearance?

POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC) received FDA 510(k) clearance on 2012-06-27, under 510(k) number K121522.

Who is the listed applicant for POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC)?

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

What is the FDA product code for POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC)?

The FDA product code for POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC) is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

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Other records listing Polyremedy, 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.

K092351POLY FIT + ABSORBING AND HIGH ABSORBING ANTIMICROBIAL DRESSINGSK092348POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGS

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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