Device Classification Name |
cuff, nerve
|
510(k) Number |
K131541 |
FOIA Releasable 510(k) |
K131541
|
Device Name |
FLEXIBLE COOAGEN NERVE CUFF |
Applicant |
COLLAGEN MATRIX, INC. |
15 THORNTON ROAD |
OAKLAND,
NJ
07436
|
|
Applicant Contact |
PEGGY HANSEN |
Correspondent |
COLLAGEN MATRIX, INC. |
15 THORNTON ROAD |
OAKLAND,
NJ
07436
|
|
Correspondent Contact |
PEGGY HANSEN |
Regulation Number | 882.5275
|
Classification Product Code |
|
Date Received | 05/29/2013 |
Decision Date | 04/03/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|