Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K070101 |
Device Name |
UNIBLATE ELECTROSURGICAL DEVICE |
Applicant |
RITA MEDICAL SYSTEMS, INC. |
46421 LANDING PARKWAY |
FEMONT,
CA
94538
|
|
Applicant Contact |
KAM H LEUNG |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
455 E. TRIMBLE ROAD |
SAN JOSE,
CA
95131 -1230
|
|
Correspondent Contact |
MORTEN SIMON CHRISTENSEN |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 01/10/2007 |
Decision Date | 02/14/2007 |
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
|