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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 K113700
Device Name VIAVALVE SAFETY IV CATHETER
Applicant
SMITHS MEDICAL ASD, INC.
201 WEST QUEEN ST.
SOUTHINGTON,  CT  06489
Applicant Contact BRIAN FARIAS
Correspondent
SMITHS MEDICAL ASD, INC.
201 WEST QUEEN ST.
SOUTHINGTON,  CT  06489
Correspondent Contact BRIAN FARIAS
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received12/16/2011
Decision Date 03/14/2012
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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