OPTISTAR ELITE INJECTION SYSTEM


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

Correspodent Contact dale moore
Regulation Number 870.1650
Classification Product Code
DXT  
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