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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K944875
Device Name ANGIOMAT 3000, 6000, CT INJECTOR
Applicant
Lievel-Flarsheim Co.
2111 E. Galraith Rd.
P.O. Box 156305
Oh,  OH  45215
Applicant Contact M L FRIEDMAN
Correspondent
Lievel-Flarsheim Co.
2111 E. Galraith Rd.
P.O. Box 156305
Oh,  OH  45215
Correspondent Contact M L FRIEDMAN
Regulation Number870.1650
Classification Product Code
DXT  
Date Received10/03/1994
Decision Date 01/04/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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