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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

Decision Date2019-02-14
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

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

When was Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing approved by the FDA?

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

What company makes 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 manufactured by Winner Medical Co., Ltd..

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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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.