FMX314 Surgical Platform— 510(k) K160797

Substantially Equivalent

Fortimedix Surgical B.V.

FDA 510(k) clearance K160797 for FMX314 Surgical Platform, Substantially Equivalent on 2016-08-26. Applicant: Fortimedix Surgical B.V..

Clearance details

Applicant: Fortimedix Surgical B.V.
Product code: Code OTJ
Advisory panel: Gastroenterology, Urology
Date received: 2016-03-23
Decision date: 2016-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nuth, NL

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