ELPH INJECTION SYSTEM


Device Classification Name

injector and syringe, angiographic

510(k) Number K022116
Device Name ELPH INJECTION SYSTEM
Original Applicant
MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
2111 east galbraith rd.
cincinnati, 
OH 
45237

Original Contact ellis rogers
Regulation Number 870.1650
Classification Product Code
DXT  
Date Received 07/01/2002
Decision Date 07/26/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No