Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K120116 |
Device Name |
SERF ABLATION SYSTEM SERF ABLATION NEEDLE |
Applicant |
THERMEDICAL |
1835 MARKET STREET |
29TH FLOOR |
PHILADELPHIA,
PA
19103
|
|
Applicant Contact |
JANICE M HOGAN |
Correspondent |
THERMEDICAL |
1835 MARKET STREET |
29TH FLOOR |
PHILADELPHIA,
PA
19103
|
|
Correspondent Contact |
JANICE M HOGAN |
Regulation Number | 878.4400 |
Classification Product Code |
|
Date Received | 01/13/2012 |
Decision Date | 10/01/2012 |
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
|
Predetermined Change Control Plan Authorized |
No
|