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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 K941429
Device Name IV CATHETER AND OBTURATOR
Applicant
Becton Dickinson Vascular Access, Inc.
Calle F. Bustamante S/N
Nogales, Sonora,  MX 84000
Applicant Contact C. J WELLE
Correspondent
Becton Dickinson Vascular Access, Inc.
Calle F. Bustamante S/N
Nogales, Sonora,  MX 84000
Correspondent Contact C. J WELLE
Regulation Number880.5200
Classification Product Code
FOS  
Date Received03/24/1994
Decision Date 01/04/1995
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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