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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 K162894
Device Name AccuCath Intravascular Catheter
Applicant
C.R.BARD, INC.
605 N 5600 W
SALT LAKE CITY,  UT  84116
Applicant Contact JACOB LEE
Correspondent
C.R.BARD, INC.
605 N 5600 W
SALT LAKE CITY,  UT  84116
Correspondent Contact JACOB LEE
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received10/17/2016
Decision Date 11/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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