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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anesthesia Conduction Kit
510(k) Number K012584
Device Name MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT
Applicant
Bd
1 Becton Dr. Mc226
Franklin Lakes,  NJ  07417
Applicant Contact PASQUALE AMATO
Correspondent
Bd
1 Becton Dr. Mc226
Franklin Lakes,  NJ  07417
Correspondent Contact PASQUALE AMATO
Regulation Number868.5140
Classification Product Code
CAZ  
Subsequent Product Code
BSP  
Date Received08/10/2001
Decision Date 09/06/2001
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
Recalls CDRH Recalls
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