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FDA 510(k)

Silver High Performance Dressing

K-Number: K183645 · 2019-05-29

ApplicantAdvanced Medical Solutions, Ltd.
Decision Date2019-05-29
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Silver High Performance Dressing is a medical device manufactured by Advanced Medical Solutions, Ltd.. It received FDA 510(k) clearance on 2019-05-29 under approval number K183645. 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 Silver High Performance Dressing?

Silver High Performance Dressing is a medical device that received FDA 510(k) clearance on 2019-05-29. It is manufactured by Advanced Medical Solutions, Ltd.. The 510(k) number is K183645.

When was Silver High Performance Dressing approved by the FDA?

Silver High Performance Dressing received FDA 510(k) clearance on 2019-05-29, under approval number K183645.

What company makes Silver High Performance Dressing?

Silver High Performance Dressing is manufactured by Advanced Medical Solutions, Ltd..

What is the FDA product code for Silver High Performance Dressing?

The FDA product code for Silver High Performance Dressing is FRO. This falls under the Anesthesiology category.

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Other Devices by Advanced Medical Solutions, Ltd.

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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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