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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. MC 226
FRANKLIN LAKES,  NJ  07417
Applicant Contact PASQUALE AMATO
Correspondent
BD
1 BECTON DR. MC 226
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
Recalls CDRH Recalls
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