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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 K050456
Device Name MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM
Applicant
Medrad, Inc.
One Medrad Dr.
Indianola,  PA  15051
Applicant Contact GEOFF M FATZINGER
Correspondent
Medrad, Inc.
One Medrad Dr.
Indianola,  PA  15051
Correspondent Contact GEOFF M FATZINGER
Regulation Number870.1650
Classification Product Code
DXT  
Date Received02/23/2005
Decision Date 06/17/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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