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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 K200280
Device Name MEDRAD Imaging Bulk Package Transfer Spike
Applicant
Bayer Medical Care Inc.
1 Bayer Drive
Indianola,  PA  15051
Applicant Contact Leslie S O'Nan
Correspondent
Bayer Medical Care Inc.
1 Bayer Drive
Indianola,  PA  15051
Correspondent Contact Leslie S O'Nan
Regulation Number880.5440
Classification Product Code
PQH  
Date Received02/04/2020
Decision Date 07/30/2020
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
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