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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 K953790
Device Name BD PERISAFE EPIDURAL ANESTHESIA 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 Received08/14/1995
Decision Date 11/30/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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