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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
Model MS-831
Device Name MEDSOURCE IV ADMINSTRATION SET
Applicant
MEDSOURCE INTERNATIONAL, LLC.
5346 shoreline drive
mound,  MN  55318
Contact jennifer ness
Regulation Number880.5440
Classification Product Code
LHI  
Date Received02/13/2012
Decision Date 07/11/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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