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FDA 510(k)

Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing

K-Number: K181315 · 2019-02-14

ApplicantWinner Medical Co., Ltd.
Decision Date2019-02-14
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing is the device name listed in this FDA 510(k) record. The listed applicant is Winner Medical Co., Ltd.. It received FDA 510(k) clearance on 2019-02-14 under 510(k) number K181315. 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 Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing?

Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing is a medical device that received FDA 510(k) clearance on 2019-02-14. The listed applicant is Winner Medical Co., Ltd.. The 510(k) number is K181315.

When did Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing receive FDA 510(k) clearance?

Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing received FDA 510(k) clearance on 2019-02-14, under 510(k) number K181315.

Who is the listed applicant for Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing?

The FDA 510(k) record lists Winner Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing?

The FDA product code for Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing is FRO. This falls under the Anesthesiology category.

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Related Devices (Code: FRO)

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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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