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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 K932400
Device Name ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY
Applicant
B. Braun of America, Inc.
824 Twelfth Ave.
P.O. Box 4027
Bethlehem,  PA  18018
Applicant Contact CHRISTINE M HARRIS
Correspondent
B. Braun of America, Inc.
824 Twelfth Ave.
P.O. Box 4027
Bethlehem,  PA  18018
Correspondent Contact CHRISTINE M HARRIS
Regulation Number868.5150
Classification Product Code
BSP  
Subsequent Product Code
CAZ  
Date Received05/18/1993
Decision Date 12/13/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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