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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 K903390
FOIA Releasable 510(k) K903390
Device Name MEDRAD MARK V-PLUS INJECTOR
Applicant
Medrad, Inc.
271 Kappa Dr.
Pittsburgh,  PA  15238
Applicant Contact FRANCIS DOBSCHA
Correspondent
Medrad, Inc.
271 Kappa Dr.
Pittsburgh,  PA  15238
Correspondent Contact FRANCIS DOBSCHA
Regulation Number870.1650
Classification Product Code
DXT  
Date Received07/27/1990
Decision Date 09/26/1990
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
Recalls CDRH Recalls
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