Device Classification Name |
generator, lesion, radiofrequency
|
510(k) Number |
K982489 |
Device Name |
RFG-3C PLUS |
Applicant |
RADIONICS, INC. |
22 TERRY AVE. |
BURLINGTON,
MA
01803 -2516
|
|
Applicant Contact |
JEFFREY R MANNION |
Correspondent |
RADIONICS, INC. |
22 TERRY AVE. |
BURLINGTON,
MA
01803 -2516
|
|
Correspondent Contact |
JEFFREY R MANNION |
Regulation Number | 882.4400
|
Classification Product Code |
|
Date Received | 07/17/1998 |
Decision Date | 10/05/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|