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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 K964654
Device Name BECTON DICKINSON BLUNT PLASTIC CANNULA
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1 BECTON DRIVE, BLDG 2,
MAIL CODE 226
FRANKLIN LAKES,  NJ  07417
Applicant Contact GREGORY W MORGAN
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1 BECTON DRIVE, BLDG 2,
MAIL CODE 226
FRANKLIN LAKES,  NJ  07417
Correspondent Contact GREGORY W MORGAN
Regulation Number880.5570
Classification Product Code
FMI  
Date Received11/20/1996
Decision Date 04/02/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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