ENDOFLOW II - Irrigation, Warming and Suction System— 510(k) K152278

Substantially Equivalent

Promepla Sam

FDA 510(k) clearance K152278 for ENDOFLOW II - Irrigation, Warming and Suction System, Substantially Equivalent on 2016-02-09. Applicant: Promepla Sam.

Clearance details

Applicant: Promepla Sam
Product code: Code OCX
Advisory panel: Gastroenterology, Urology
Date received: 2015-08-12
Decision date: 2016-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monaco, MC

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