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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K944931
Device Name BECTON DICKINSON BLUNT STEEL CANNULA
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1 BECTON DRIVE, BLDG 2,
MAIL CODE 226
FRANKLIN LAKES,  NJ  07417
Applicant Contact GREG W MORGAN
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1 BECTON DRIVE, BLDG 2,
MAIL CODE 226
FRANKLIN LAKES,  NJ  07417
Correspondent Contact GREG W MORGAN
Regulation Number880.5570
Classification Product Code
FMI  
Date Received10/06/1994
Decision Date 08/29/1995
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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