Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K982556 |
Device Name |
LEVEEN NEEDLE ELECTRODE |
Applicant |
RADIOTHERAPEUTICS CORP. |
2685 MARINE WAY, SUITE 1408 |
MOUNTAIN VIEW,
CA
94043
|
|
Applicant Contact |
COLIN J NICHOLS |
Correspondent |
RADIOTHERAPEUTICS CORP. |
2685 MARINE WAY, SUITE 1408 |
MOUNTAIN VIEW,
CA
94043
|
|
Correspondent Contact |
COLIN J NICHOLS |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 07/22/1998 |
Decision Date | 04/06/2000 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|