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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 K120839
Device Name NOVACATH SECURE IV CATHETER SYSTEM-18G
Original Applicant
TANGENT MEDICAL TECHNOLOGIES, INC.
8170 jackson rd, ste a
ann arbor,  MI  48103
Original Contact kay fuller
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received03/20/2012
Decision Date 07/20/2012
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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