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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name syringe, piston
510(k) Number K010890
Device Name BD ULTRA-FINE II INSULIN SYRINGE-MINI NEEDLE, MODEL 30G * 3/16 (5MM)
Applicant
BECTON DICKINSON AND CO.
1 BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1880
Applicant Contact PETER ZURLO
Correspondent
BECTON DICKINSON AND CO.
1 BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1880
Correspondent Contact PETER ZURLO
Regulation Number880.5860
Classification Product Code
FMF  
Date Received03/26/2001
Decision Date 04/19/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
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