Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K964844 |
Device Name |
CONMED: STAT 2 AND STAT 2 PUMPETTE EXTENSION SETS AND MASTERFLOW AND MASTERFLOW PUMPETTE PRIMARY SETS |
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 | 880.5440
|
Classification Product Code |
|
Date Received | 12/03/1996 |
Decision Date | 03/24/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|