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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Umbilical Artery
510(k) Number K890685
Device Name BARD UMBILICAL VESSEL CATHETER
Applicant
C.R. Bard, Inc.
One Park W.
Tewksbury,  MA  01876 -1234
Applicant Contact KEVIN E DALY
Correspondent
C.R. Bard, Inc.
One Park W.
Tewksbury,  MA  01876 -1234
Correspondent Contact KEVIN E DALY
Regulation Number880.5200
Classification Product Code
FOS  
Date Received02/09/1989
Decision Date 02/28/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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