Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K012315 |
Device Name |
LEVEEN ELECTRODE |
Applicant |
RADIOTHERAPEUTICS CORP. |
1308 BORREGAS AVE.SUITE 200 |
SUNNYVALE,
CA
94089
|
|
Applicant Contact |
KIRSTEN VALLEY |
Correspondent |
RADIOTHERAPEUTICS CORP. |
1308 BORREGAS AVE.SUITE 200 |
SUNNYVALE,
CA
94089
|
|
Correspondent Contact |
KIRSTEN VALLEY |
Regulation Number | 878.4400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/23/2001 |
Decision Date | 10/11/2001 |
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
|
Recalls |
CDRH Recalls
|