Device Classification Name |
Cuff, Nerve
|
510(k) Number |
K002098 |
Device Name |
SALUMEDICA NERVE CUFF |
Applicant |
SALUMEDICA, L.L.C. |
112 KROG ST. |
SUITE 4 |
ATLANTA,
GA
30307
|
|
Applicant Contact |
DAVID N KU |
Correspondent |
SALUMEDICA, L.L.C. |
112 KROG ST. |
SUITE 4 |
ATLANTA,
GA
30307
|
|
Correspondent Contact |
DAVID N KU |
Regulation Number | 882.5275
|
Classification Product Code |
|
Date Received | 07/11/2000 |
Decision Date | 11/24/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|