Device Classification Name |
cuff, nerve
|
510(k) Number |
K100382 |
Device Name |
SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331 |
Applicant |
SALUMEDICA, L.L.C. |
931 E PONCE DE LEON AVE |
ATLANTA,
GA
30306
|
|
Applicant Contact |
BOB BRADEN |
Correspondent |
SALUMEDICA, L.L.C. |
931 E PONCE DE LEON AVE |
ATLANTA,
GA
30306
|
|
Correspondent Contact |
BOB BRADEN |
Regulation Number | 882.5275
|
Classification Product Code |
|
Date Received | 02/16/2010 |
Decision Date | 08/05/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|