Device Classification Name |
injector and syringe, angiographic
|
510(k) Number |
K912944 |
Device Name |
CT 8000 DIGITAL INJECTION SYSTEM |
Applicant |
MALLINCKRODT GROUP, INC. |
2111 EAST GALBRAITH RD. |
P.O. BOX 156305 |
CINCINNATI,
OH
45215 -6305
|
|
Applicant Contact |
MARK L FREIDMAN |
Correspondent |
MALLINCKRODT GROUP, INC. |
2111 EAST GALBRAITH RD. |
P.O. BOX 156305 |
CINCINNATI,
OH
45215 -6305
|
|
Correspondent Contact |
MARK L FREIDMAN |
Regulation Number | 870.1650
|
Classification Product Code |
|
Date Received | 07/05/1991 |
Decision Date | 02/04/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|