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FDA 510(k)

Collagentex Rx-1

K-Number: K162022 · 2016-12-22

ApplicantTanses Technologies, Inc.
Decision Date2016-12-22
Product CodeNHN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Collagentex Rx-1 is the device name listed in this FDA 510(k) record. The listed applicant is Tanses Technologies, Inc.. It received FDA 510(k) clearance on 2016-12-22 under 510(k) number K162022. 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-1?

Collagentex Rx-1 is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Tanses Technologies, Inc.. The 510(k) number is K162022.

When did Collagentex Rx-1 receive FDA 510(k) clearance?

Collagentex Rx-1 received FDA 510(k) clearance on 2016-12-22, under 510(k) number K162022.

Who is the listed applicant for Collagentex Rx-1?

The FDA 510(k) record lists Tanses Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Collagentex Rx-1?

The FDA product code for Collagentex Rx-1 is NHN.

Other records listing Tanses Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K180585Collagentex Rx-6K152412T-32;T-40;T-44;T-52;T-72;TT-50

Related Devices (Code: NHN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254024MR5 Activ ProMulti Radiance Medical, Inc.K251903Erchonia DPN Laser (Model# EVRL)Erchonia CorporationK252273Therapy USDmc Importação E Exportação DE Equipamentos LtdaK241057Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)Wuhan Guangdun Technology Co.,Ltd..K232813Therapy EC, Therapy XTDmc Importacao E Exportacao DE Equipamentos LtdaK231409Erchonia FX-405Erchonia Corporation

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.

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