Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K021299 |
Device Name |
CONMED HEATWAVE HAND-CONTROLLED ELETRODE |
Applicant |
CONMED CORP. |
525 FRENCH RD. |
UTICA,
NY
13502
|
|
Applicant Contact |
IRA D DUESLER |
Correspondent |
CONMED CORP. |
525 FRENCH RD. |
UTICA,
NY
13502
|
|
Correspondent Contact |
IRA D DUESLER |
Regulation Number | 878.4400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/24/2002 |
Decision Date | 06/26/2002 |
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
|