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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 K161723
Device Name ulrich Transfer Set
Applicant
ulrich GmbH & Co. KG
Buchbrunnenweg 12
Ulm,  DE 89081
Applicant Contact Sven Erdmann
Correspondent
MethodSense, Inc.
PO Box 110352
Durham,  NC  27709
Correspondent Contact Rita King
Regulation Number880.5440
Classification Product Code
PQH  
Date Received06/22/2016
Decision Date 12/21/2016
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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