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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 K072419
Device Name ADVANTIV SAFETY I.V. CATHETER
Applicant
SMITHS MEDICAL ASD, INC.
6250 SHIER RINGS RD.
DUBLIN,  OH  43016
Applicant Contact BARBARA LAW
Correspondent
SMITHS MEDICAL ASD, INC.
6250 SHIER RINGS RD.
DUBLIN,  OH  43016
Correspondent Contact BARBARA LAW
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received08/28/2007
Decision Date 11/09/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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