Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K030142 |
Device Name |
THERMACOOL TC SYSTEM |
Applicant |
THERMAGE, INC. |
4058 POINT EDEN WAY |
HAYWARD,
CA
94545 -3721
|
|
Applicant Contact |
PAMELA M BUCKMAN |
Correspondent |
THERMAGE, INC. |
4058 POINT EDEN WAY |
HAYWARD,
CA
94545 -3721
|
|
Correspondent Contact |
PAMELA M BUCKMAN |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 01/15/2003 |
Decision Date | 02/03/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|