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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, i.v. fluid transfer
510(k) Number K120424
Device Name MEDSOURCE IV ADMINSTRATION SET
Original Applicant
MEDSOURCE INTERNATIONAL, LLC.
5346 shoreline drive
mound,  MN  55318
Original Contact jennifer ness
Regulation Number880.5440
Classification Product Code
LHI  
Date Received02/13/2012
Decision Date 07/11/2012
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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