Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K943327 |
Device Name |
CONMED SELECTONE MINIMAL ACCESS SURGERY INSTRUMENTS |
Applicant |
CONMED CORP. |
310 BROAD ST. |
UTICA,
NY
13501 -1203
|
|
Applicant Contact |
IRA D DUESLER, JR. |
Correspondent |
CONMED CORP. |
310 BROAD ST. |
UTICA,
NY
13501 -1203
|
|
Correspondent Contact |
IRA D DUESLER, JR. |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 07/12/1994 |
Decision Date | 11/07/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|