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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
Applicant
Medsource International, LLC
5346 Shoreline Dr.
Mound,  MN  55318
Applicant Contact JENNIFER NESS
Correspondent
Medsource International, LLC
5346 Shoreline Dr.
Mound,  MN  55318
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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