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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 K132928
Device Name MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE
Applicant
Medrad, Inc. / Bayer Medical Care, Inc.
One Medrad Dr.
Indianola,  PA  15051
Applicant Contact LISA A EWING
Correspondent
Medrad, Inc. / Bayer Medical Care, Inc.
One Medrad Dr.
Indianola,  PA  15051
Correspondent Contact LISA A EWING
Regulation Number870.1650
Classification Product Code
DXT  
Date Received09/18/2013
Decision Date 01/23/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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