Bi-Flex Evo— 510(k) K182144

Substantially Equivalent

Promepla Sam

FDA 510(k) clearance K182144 for Bi-Flex Evo, Substantially Equivalent on 2018-09-07. Applicant: Promepla Sam. Device class: 2.

Clearance details

Applicant: Promepla Sam
Product code: Code KNY
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2018-08-08
Decision date: 2018-09-07
Decision: Substantially Equivalent
Clearance type: Special
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.