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FDA 510(k)

Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border

K-Number: K191819 · 2020-05-14

ApplicantWinner Medical Co., Ltd.
Decision Date2020-05-14
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border is a medical device manufactured by Winner Medical Co., Ltd.. It received FDA 510(k) clearance on 2020-05-14 under approval number K191819. 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 Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border?

Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border is a medical device that received FDA 510(k) clearance on 2020-05-14. It is manufactured by Winner Medical Co., Ltd.. The 510(k) number is K191819.

When was Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border approved by the FDA?

Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border received FDA 510(k) clearance on 2020-05-14, under approval number K191819.

What company makes Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border?

Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border is manufactured by Winner Medical Co., Ltd..

What is the FDA product code for Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border?

The FDA product code for Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

NCT07549737 Effectiveness of Silicone Superabsorbent Polymer Dressings for Chronic Wound Management COMPLETED NCT06717308 Evaluation of a Switchable Acrylic Adhesive Drape for Safer Removal in Negative Pressure Wound Therapy Applications. RECRUITING

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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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