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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 Dr., Bldg. 2,
Mail Code 226
Franklin Lakes,  NJ  07417
Applicant Contact GREG MORGAN
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1 Becton Dr., 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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