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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 K042934
Device Name 1BD SOLOSHOT IX SYRINGE
Applicant
Becton, Dickinson & CO
1 Becton Dr.
Franklin Lakes,  NJ  07417
Applicant Contact PETER ZURLO
Correspondent
Becton, Dickinson & CO
1 Becton Dr.
Franklin Lakes,  NJ  07417
Correspondent Contact PETER ZURLO
Regulation Number880.5860
Classification Product Code
FMF  
Date Received10/25/2004
Decision Date 10/28/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Expedited Review Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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