Collagentex Rx-6— 510(k) K180585

Substantially Equivalent

Tanses Technologies, Inc.

FDA 510(k) clearance K180585 for Collagentex Rx-6, Substantially Equivalent on 2018-05-11. Applicant: Tanses Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Tanses Technologies, Inc.
Product code: Code NHN
Device class: Class 2
Regulation: 21 CFR 890.5500
Advisory panel: Physical Medicine
Date received: 2018-03-05
Decision date: 2018-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laval Quebec, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.