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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 K193028
Device Name MEDRAD Mark 7 Arterion Injection System
Applicant
Bayer Medical Care Inc.
1 Bayer Drive
indianola,  PA  15051
Applicant Contact kelly frank
Correspondent
Bayer Medical Care Inc.
1 Bayer Drive
indianola,  PA  15051
Correspondent Contact kelly frank
Regulation Number870.1650
Classification Product Code
DXT  
Date Received10/30/2019
Decision Date 12/05/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General Hospital
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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