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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
Predetermined Change
Control Plan Authorized		 No
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