510(k) K103081

COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE by Biom'Up Sas — Product Code JXI

K103081 is an FDA 510(k) premarket notification submitted by Biom'Up Sas for the device "COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE". The FDA issued a decision of Substantially Equivalent on March 2, 2012. The device falls under product code JXI (Cuff, Nerve), a Class II device regulated under 21 CFR 882.5275. Biom'Up Sas has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2012
Date Received
October 19, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cuff, Nerve
Device Class
Class II
Regulation Number
882.5275
Review Panel
NE
Submission Type