Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K081634 |
Device Name |
CONMED GOLDVAC INTEGRATED SMOKE EVACUATION PENCIL |
Applicant |
CONMED CORPORATION |
14603 E. FREMONT AVE. |
CENTENNIAL,
CO
80112
|
|
Applicant Contact |
SHAWN RIEDEL |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
DANIEL W LEHTONEN |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 06/11/2008 |
Decision Date | 06/25/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|