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

Name: FDA 510(k) clearance K152278
Creator: U.S. Food and Drug Administration
Published: 2016-02-09

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. Device class: 2.

Clearance details

Applicant: Promepla Sam
Product code: Code OCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2015-08-12
Decision date: 2016-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monaco, MC

Download summary PDF View on FDA.gov ↗

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