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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K131555
Device Name MEDSOURCE IV SAFETY CATHETER
Applicant
MEDSOURCE INTERNATIONAL, LLC.
5346 SHORELINE DR.
MOUND,  MN  55364
Applicant Contact JENNIFER NESS
Correspondent
MEDSOURCE INTERNATIONAL, LLC.
5346 SHORELINE DR.
MOUND,  MN  55364
Correspondent Contact JENNIFER NESS
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received05/29/2013
Decision Date 01/31/2014
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 No
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