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FDA 510(k)

POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGS

K-Number: K092348 · 2010-04-08

ApplicantPolyremedy, Inc.
Decision Date2010-04-08
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGS is the device name listed in this FDA 510(k) record. The listed applicant is Polyremedy, Inc.. It received FDA 510(k) clearance on 2010-04-08 under 510(k) number K092348. 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 POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGS?

POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGS is a medical device that received FDA 510(k) clearance on 2010-04-08. The listed applicant is Polyremedy, Inc.. The 510(k) number is K092348.

When did POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGS receive FDA 510(k) clearance?

POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGS received FDA 510(k) clearance on 2010-04-08, under 510(k) number K092348.

Who is the listed applicant for POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGS?

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 POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGS?

The FDA product code for POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGS is FRO. This falls under the Anesthesiology category.

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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.

K121522POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC)K092351POLY FIT + ABSORBING AND HIGH ABSORBING 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.

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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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