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FDA 510(k)

Collagentex Rx-6

K-Number: K180585 · 2018-05-11

Decision Date2018-05-11
Product CodeNHN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Collagentex Rx-6 is a medical device manufactured by Tanses Technologies, Inc.. It received FDA 510(k) clearance on 2018-05-11 under approval number K180585. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Collagentex Rx-6?

Collagentex Rx-6 is a medical device that received FDA 510(k) clearance on 2018-05-11. It is manufactured by Tanses Technologies, Inc.. The 510(k) number is K180585.

When was Collagentex Rx-6 approved by the FDA?

Collagentex Rx-6 received FDA 510(k) clearance on 2018-05-11, under approval number K180585.

What company makes Collagentex Rx-6?

Collagentex Rx-6 is manufactured by Tanses Technologies, Inc..

What is the FDA product code for Collagentex Rx-6?

The FDA product code for Collagentex Rx-6 is NHN.

Other Devices by Tanses Technologies, Inc.

Related Devices (Code: NHN)

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.