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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 K011103
Device Name BD SPRING BASED SYRINGE
Original Applicant
BD
1 becton dr. mc 226
franklin lakes,  NJ  07417
Original Contact greg w morgan
Regulation Number880.5860
Classification Product Code
MEG  
Subsequent Product Code
FMF  
Date Received04/11/2001
Decision Date 06/13/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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