Device Classification Name |
cuff, nerve
|
510(k) Number |
K112267 |
Device Name |
NEUROLAC(R) NERVE GUIDE |
Applicant |
Polyganics BV |
ROZENBURGLAAN 15A |
GRONINGEN,
NL
9727-DL
|
|
Applicant Contact |
BETTY IJMKER |
Correspondent |
Polyganics BV |
ROZENBURGLAAN 15A |
GRONINGEN,
NL
9727-DL
|
|
Correspondent Contact |
BETTY IJMKER |
Regulation Number | 882.5275
|
Classification Product Code |
|
Date Received | 08/08/2011 |
Decision Date | 10/20/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|