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FDA 510(k)

Polyver Silver Alginate Dressing (Prescription and OTC)

K-Number: K230190 · 2023-11-17

ApplicantRoosin Medical Co., Ltd.
Decision Date2023-11-17
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Polyver Silver Alginate Dressing (Prescription and OTC) is a medical device manufactured by Roosin Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-11-17 under approval number K230190. 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 Polyver Silver Alginate Dressing (Prescription and OTC)?

Polyver Silver Alginate Dressing (Prescription and OTC) is a medical device that received FDA 510(k) clearance on 2023-11-17. It is manufactured by Roosin Medical Co., Ltd.. The 510(k) number is K230190.

When was Polyver Silver Alginate Dressing (Prescription and OTC) approved by the FDA?

Polyver Silver Alginate Dressing (Prescription and OTC) received FDA 510(k) clearance on 2023-11-17, under approval number K230190.

What company makes Polyver Silver Alginate Dressing (Prescription and OTC)?

Polyver Silver Alginate Dressing (Prescription and OTC) is manufactured by Roosin Medical Co., Ltd..

What is the FDA product code for Polyver Silver Alginate Dressing (Prescription and OTC)?

The FDA product code for Polyver Silver Alginate Dressing (Prescription and OTC) is FRO. This falls under the Anesthesiology category.

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Other Devices by Roosin Medical Co., Ltd.

K181478Roosin Xeroform Petrolatum Dressing K231088Copper Foam Dressing (Prescription and OTC)

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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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