Device Classification Name |
dura substitute |
|||
---|---|---|---|---|
510(k) Number | K960470 | |||
Device Name | NEURO-PATCH | |||
Applicant |
|
|||
Applicant Contact | victoria mackinnon | |||
Correspondent |
|
|||
Correspodent Contact | victoria mackinnon | |||
Regulation Number | 882.5910 | |||
Classification Product Code |
|
|||
Date Received | 02/01/1996 | |||
Decision Date | 05/10/1996 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
Neurology |
|||
510k Review Panel |
Neurology |
|||
summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |