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FDA 510(k)

High Strength Suture

K-Number: K192637 · 2020-03-02

Decision Date2020-03-02
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

High Strength Suture is a medical device manufactured by Yunyi (Beijing) Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2020-03-02 under approval number K192637. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the High Strength Suture?

High Strength Suture is a medical device that received FDA 510(k) clearance on 2020-03-02. It is manufactured by Yunyi (Beijing) Medical Device Co., Ltd.. The 510(k) number is K192637.

When was High Strength Suture approved by the FDA?

High Strength Suture received FDA 510(k) clearance on 2020-03-02, under approval number K192637.

What company makes High Strength Suture?

High Strength Suture is manufactured by Yunyi (Beijing) Medical Device Co., Ltd..

What is the FDA product code for High Strength Suture?

The FDA product code for High Strength Suture is GAT.

Other Devices by Yunyi (Beijing) Medical Device Co., Ltd.

Related Devices (Code: GAT)

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.