Device Classification Name |
stimulator, neuromuscular, external functional
|
510(k) Number |
K080219 |
Device Name |
MODIFICATION TO:NESS L300 |
Applicant |
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS |
25103 RYE CANYON LOOP |
VALENCIA,
CA
91355
|
|
Applicant Contact |
EVAN ROSENFELD |
Correspondent |
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS |
25103 RYE CANYON LOOP |
VALENCIA,
CA
91355
|
|
Correspondent Contact |
EVAN ROSENFELD |
Regulation Number | 882.5810
|
Classification Product Code |
|
Date Received | 01/29/2008 |
Decision Date | 02/28/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|