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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 K954953
Device Name B-D DURASAFE COMBINED SPINAL EPIDURAL (CSE) TRAY
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
One Becton Dr.
Franklin Lakes,  NJ  07417 -1880
Applicant Contact GREGORY W MORGAN
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
One Becton Dr.
Franklin Lakes,  NJ  07417 -1880
Correspondent Contact GREGORY W MORGAN
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received10/30/1995
Decision Date 05/20/1996
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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