Device Classification Name |
cuff, nerve
|
510(k) Number |
K041620 |
Device Name |
NEURA WRAP NERVE PROTECTOR |
Applicant |
INTEGRA LIFESCIENCES CORP. |
311 ENTERPRISE DR. |
PLAINSBORO,
NJ
08536
|
|
Applicant Contact |
DIANA M BORDON |
Correspondent |
INTEGRA LIFESCIENCES CORP. |
311 ENTERPRISE DR. |
PLAINSBORO,
NJ
08536
|
|
Correspondent Contact |
DIANA M BORDON |
Regulation Number | 882.5275
|
Classification Product Code |
|
Date Received | 06/16/2004 |
Decision Date | 07/16/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|