HC-1 AND HC-1 CLASSIC— 510(k) K131852

Name: FDA 510(k) clearance K131852
Creator: U.S. Food and Drug Administration
Published: 2014-04-17

Substantially Equivalent

Transcendencias Comerciales SL Transcom

FDA 510(k) clearance K131852 for HC-1 AND HC-1 CLASSIC, Substantially Equivalent on 2014-04-17. Applicant: Transcendencias Comerciales SL Transcom. Device class: 2.

Clearance details

Applicant: Transcendencias Comerciales SL Transcom
Product code: Code KPL
Device class: Class 2
Regulation: 21 CFR 876.5220
Advisory panel: Gastroenterology, Urology
Date received: 2013-06-21
Decision date: 2014-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Sebastian, Guipuzcoa, ES

Download summary PDF View on FDA.gov ↗

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