Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K010060 |
Device Name |
RITA STARBURST XLI ELECTROSURGICAL DEVICE |
Applicant |
RITA MEDICAL SYSTEMS |
967 NORTH SHORELINE BLVD. |
MOUNTAIN VIEW,
CA
94043
|
|
Applicant Contact |
ERIN MAZZONE |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
1655 SCOTT BLVD. |
SANTA CLARA,
CA
95050
|
|
Correspondent Contact |
MICHAEL KWAN |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 01/08/2001 |
Decision Date | 01/23/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|