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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name I.V. Start Kit
510(k) Number K943941
Device Name SAFESTART VASCULAR ACCESS START KIT
Applicant
BECTON DICKINSON VASCULAR ACCESS, INC.
9450 SOUTH STATE ST.
SANDY,  UT  84070
Applicant Contact C.J. WELLE
Correspondent
BECTON DICKINSON VASCULAR ACCESS, INC.
9450 SOUTH STATE ST.
SANDY,  UT  84070
Correspondent Contact C.J. WELLE
Regulation Number880.5200
Classification Product Code
LRS  
Date Received08/12/1994
Decision Date 10/20/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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