LigaPASS— 510(k) K160698

Substantially Equivalent

Medicrea International SA

FDA 510(k) clearance K160698 for LigaPASS, Substantially Equivalent on 2016-09-02. Applicant: Medicrea International SA. Device class: 2.

Clearance details

Applicant: Medicrea International SA
Product code: Code OWI
Device class: Class 2
Regulation: 21 CFR 888.3010
Advisory panel: Orthopedic
Date received: 2016-03-14
Decision date: 2016-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neyron, FR

Download summary PDF View on FDA.gov ↗

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