Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K982130 |
Device Name |
RETURN ELECTRODE CLAMP SHELL CORD MODEL RC 201 |
Applicant |
NEW DEANTRONICS, LTD. |
4655 KIRKWOOD COURT |
BOULDER,
CO
80301
|
|
Applicant Contact |
LEWIS WARD |
Correspondent |
NEW DEANTRONICS, LTD. |
4655 KIRKWOOD COURT |
BOULDER,
CO
80301
|
|
Correspondent Contact |
LEWIS WARD |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 06/17/1998 |
Decision Date | 08/07/1998 |
Decision |
Substantially Equivalent
(SESE) |
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
|