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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name syringe, antistick
510(k) Number K992734
Device Name BECTON DICKINSON SYRINGE
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1 BECTON DRIVE, BLDG 2,
MAIL CODE 226
FRANKLIN LAKES,  NJ  07417
Applicant Contact GREG MORGAN
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1 BECTON DRIVE, BLDG 2,
MAIL CODE 226
FRANKLIN LAKES,  NJ  07417
Correspondent Contact GREG MORGAN
Regulation Number880.5860
Classification Product Code
MEG  
Date Received08/13/1999
Decision Date 10/01/1999
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
Recalls CDRH Recalls
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