Device Classification Name |
injector and syringe, angiographic
|
510(k) Number |
K963071 |
Device Name |
ANGIOMAT ILLUMENA |
Applicant |
MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS |
2111 EAST GALBRAITH RD. |
CINCINNATI,
OH
45237
|
|
Applicant Contact |
BRIDGET DRAKE |
Correspondent |
MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS |
2111 EAST GALBRAITH RD. |
CINCINNATI,
OH
45237
|
|
Correspondent Contact |
BRIDGET DRAKE |
Regulation Number | 870.1650
|
Classification Product Code |
|
Date Received | 08/07/1996 |
Decision Date | 09/23/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|