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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 K143538
Device Name MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit
Applicant
BAYER MEDICAL CARE INC.
1 BAYER DRIVE
INDIANOLA,  PA  15051
Applicant Contact LISA A. EWING
Correspondent
BAYER MEDICAL CARE INC.
1 BAYER DRIVE
INDIANOLA,  PA  15051
Correspondent Contact LISA A. EWING
Regulation Number870.1650
Classification Product Code
DXT  
Date Received12/15/2014
Decision Date 08/14/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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