Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K984552 |
Device Name |
COOL-TIP RF SYSTEM |
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 | 878.4400
|
Classification Product Code |
|
Date Received | 12/22/1998 |
Decision Date | 03/05/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|