Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K042216 |
Device Name |
COOL-TIP RF ABLATION SYSTEM |
Applicant |
VALLEYLAB |
5920 LONGBOW DR. |
BOULDER,
CO
80301
|
|
Applicant Contact |
CHARLES COPPERBERG |
Correspondent |
VALLEYLAB |
5920 LONGBOW DR. |
BOULDER,
CO
80301
|
|
Correspondent Contact |
CHARLES COPPERBERG |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 08/16/2004 |
Decision Date | 11/12/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|