Device Classification Name |
Insufflator, Laparoscopic
|
510(k) Number |
K943954 |
Device Name |
ASPEN SURGICAL SYSTEMS INSUFFLATION TUBING SET WITH FILTER |
Applicant |
CONMED CORP. |
3040 EAST RIVER RD. |
DAYTON,
OH
45439
|
|
Applicant Contact |
IRA D DUESLER |
Correspondent |
CONMED CORP. |
3040 EAST RIVER RD. |
DAYTON,
OH
45439
|
|
Correspondent Contact |
IRA D DUESLER |
Regulation Number | 884.1730
|
Classification Product Code |
|
Date Received | 08/15/1994 |
Decision Date | 11/15/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|