Device Classification Name |
Stimulator, Spinal-Cord, Implanted (Pain Relief)
|
510(k) Number |
K081208 |
Device Name |
CINCH ANCHOR, MODEL 1194 |
Applicant |
ADVANCED NEUROMODULATION SYSTEMS |
6901 PRESTON RD. |
PLANO,
TX
75024
|
|
Applicant Contact |
PENNY HOUSTON |
Correspondent |
ADVANCED NEUROMODULATION SYSTEMS |
6901 PRESTON RD. |
PLANO,
TX
75024
|
|
Correspondent Contact |
PENNY HOUSTON |
Regulation Number | 882.5880
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/29/2008 |
Decision Date | 07/18/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|