Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K032149 |
Device Name |
RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR |
Applicant |
RITA MEDICAL SYSTEMS INC |
967 N. SHORELINE BLVD. |
MOUNTAIN VIEW,
CA
94043
|
|
Applicant Contact |
KAREN J FRISCHMEYER |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
1655 SCOTT BLVD. |
SANTA CLARA,
CA
95050
|
|
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 07/14/2003 |
Decision Date | 09/09/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|