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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Iodinated Contrast Media Transfer Tubing Set
510(k) Number K173913
Device Name MEDRAD® Imaging Bulk Package Transfer Set
Applicant
Bayer U.S. LLC
1 Bayer Drive
Indianola,  PA  15051
Applicant Contact Leslie S. O'Nan
Correspondent
Bayer U.S. LLC
1 Bayer Drive
Indianola,  PA  15051
Correspondent Contact Leslie S. O'Nan
Regulation Number880.5440
Classification Product Code
PQH  
Date Received12/22/2017
Decision Date 05/04/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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