Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K052104 |
Device Name |
ULTRACLEAN HANDCONTROLLED SUCTION COAGULATOR, MODEL 130182, 130183, 130184, 130185; ULTRACLEAN FOOTCONTROLLED SUCTION |
Applicant |
CONMED CORPORATION |
14603 E. FREMONT AVE. |
CENTENNIAL,
CO
80112
|
|
Applicant Contact |
PAMELA VETTER |
Correspondent |
CONMED CORPORATION |
14603 E. FREMONT AVE. |
CENTENNIAL,
CO
80112
|
|
Correspondent Contact |
PAMELA VETTER |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 08/03/2005 |
Decision Date | 10/21/2005 |
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
|