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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 K192370
Device Name MEDRAD Stellant FLEX CT Injection System with Certegra Workstation
Applicant
Bayer Medical Care, Inc.
100 Bayer Blvd.
Whippany,  NJ  07981
Applicant Contact Alison Maloney
Correspondent
Bayer Medical Care, Inc.
100 Bayer Blvd.
Whippany,  NJ  07981
Correspondent Contact Alison Maloney
Regulation Number870.1650
Classification Product Code
DXT  
Date Received08/30/2019
Decision Date 12/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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