COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE— 510(k) K103081

Name: FDA 510(k) clearance K103081
Creator: U.S. Food and Drug Administration
Published: 2012-03-02

Substantially Equivalent

Biom'Up Sas

FDA 510(k) clearance K103081 for COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE, Substantially Equivalent on 2012-03-02. Applicant: Biom'Up Sas. Device class: 2.

Clearance details

Applicant: Biom'Up Sas
Product code: Code JXI
Device class: Class 2
Regulation: 21 CFR 882.5275
Advisory panel: Neurology
Date received: 2010-10-19
Decision date: 2012-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St-Priest, FR

Download summary PDF View on FDA.gov ↗

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