Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K935091 |
Device Name |
ASPEN SURGICAL SYSTEMS COATED BLADE ELECTRODE |
Applicant |
CONMED CORP. |
310 BROAD ST. |
UTICA,
NY
13501 -1203
|
|
Applicant Contact |
IRA D DUESLER |
Correspondent |
CONMED CORP. |
310 BROAD ST. |
UTICA,
NY
13501 -1203
|
|
Correspondent Contact |
IRA D DUESLER |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 10/25/1993 |
Decision Date | 02/28/1994 |
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
|
Recalls |
CDRH Recalls
|