Device Classification Name |
Cuff, Nerve
|
510(k) Number |
K103081 |
Device Name |
COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE |
Applicant |
BIOM'UP SAS |
8, ALLEE IRENE JOLIOT-CURIE |
ST-PRIEST,
FR
69800
|
|
Applicant Contact |
VALERIE CENTIS |
Correspondent |
BIOM'UP SAS |
8, ALLEE IRENE JOLIOT-CURIE |
ST-PRIEST,
FR
69800
|
|
Correspondent Contact |
VALERIE CENTIS |
Regulation Number | 882.5275
|
Classification Product Code |
|
Date Received | 10/19/2010 |
Decision Date | 03/02/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|