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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 K160235
Device Name ViaValve Safety I.V. Catheter
Applicant
Smiths Medical Asd, Inc.
201 W. Queen St.
Southington,  CT  06489
Applicant Contact BRIAN FARIAS
Correspondent
Smiths Medical Asd, Inc.
201 W. Queen St.
Southington,  CT  06489
Correspondent Contact BRIAN FARIAS
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received02/01/2016
Decision Date 06/30/2016
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
Recalls CDRH Recalls
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