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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K100209
Device Name BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY
Applicant
Becton, Dickinson & CO
1 Becton Dr.
Mc 237
Franklin Lakes,  NJ  07417
Applicant Contact PASQUALE AMATO
Correspondent
Becton, Dickinson & CO
1 Becton Dr.
Mc 237
Franklin Lakes,  NJ  07417
Correspondent Contact PASQUALE AMATO
Regulation Number880.5570
Classification Product Code
FMI  
Date Received01/25/2010
Decision Date 02/19/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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