Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K001161 |
Device Name |
ULTRAPEN REUSABLE PENCIL, MODEL 130350 THROUGH 130353, REUSABLE ACCESSORY ELECTRODE KIT (FOR USE WITH ULTRAPEN PENCIL), |
Applicant |
CONMEDCORP |
14603 E. FREMONT AVE. |
ENGLEWOOD,
CO
80112
|
|
Applicant Contact |
CHARLES M (MIKE) HART |
Correspondent |
CONMEDCORP |
14603 E. FREMONT AVE. |
ENGLEWOOD,
CO
80112
|
|
Correspondent Contact |
CHARLES M (MIKE) HART |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 04/10/2000 |
Decision Date | 06/07/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|