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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 K133147
Device Name BRACCO INJEENERING TRANSFER SET
Applicant
Bracco Injeneering S.A.
P.O. Box 3018
Nederland,  CO  80466
Applicant Contact THOMAS KROENKE
Correspondent
Bracco Injeneering S.A.
P.O. Box 3018
Nederland,  CO  80466
Correspondent Contact THOMAS KROENKE
Regulation Number880.5440
Classification Product Code
PQH  
Date Received10/17/2013
Decision Date 06/20/2014
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 Yes
Predetermined Change
Control Plan Authorized		 No
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