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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Conduction, Anesthetic (W/Wo Introducer)
510(k) Number K091758
Device Name BD SPINAL NEEDLE 27G
Applicant
Becton Dickson & Co.
1 Becton Dr.
Mc 237
Franklin Lakes,  NJ  07417
Applicant Contact PASQUALE AMATO
Correspondent
Becton Dickson & Co.
1 Becton Dr.
Mc 237
Franklin Lakes,  NJ  07417
Correspondent Contact PASQUALE AMATO
Regulation Number868.5150
Classification Product Code
BSP  
Date Received06/16/2009
Decision Date 10/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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