Device Classification Name |
injector and syringe, angiographic
|
510(k) Number |
K073592 |
Device Name |
OPTISTAR ELITE INJECTION SYSTEM |
Applicant |
MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS |
2111 EAST GALBRAITH RD. |
CINCINNATI,
OH
45237
|
|
Applicant Contact |
DALE MOORE |
Correspondent |
MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS |
2111 EAST GALBRAITH RD. |
CINCINNATI,
OH
45237
|
|
Correspondent Contact |
DALE MOORE |
Regulation Number | 870.1650
|
Classification Product Code |
|
Date Received | 12/20/2007 |
Decision Date | 05/07/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|