Device Classification Name |
generator, lesion, radiofrequency
|
510(k) Number |
K082051 |
Device Name |
COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4 |
Applicant |
COSMAN MEDICAL, INC. |
76 CAMBRIDGE ST. |
BURLINGTON,
MA
01803 -4140
|
|
Applicant Contact |
LOUIS FALCONE |
Correspondent |
COSMAN MEDICAL, INC. |
76 CAMBRIDGE ST. |
BURLINGTON,
MA
01803 -4140
|
|
Correspondent Contact |
LOUIS FALCONE |
Regulation Number | 882.4400
|
Classification Product Code |
|
Date Received | 07/18/2008 |
Decision Date | 10/16/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|