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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 K932569
Device Name PENCIL POINT SPINAL NEEDLE AND TRAY
Applicant
B. Braun OF America, Inc.
824 Twelfth Ave.
P.O. Box 4027
Bethlehem,  PA  18018 -0027
Applicant Contact CHRISTINE HARRIS
Correspondent
B. Braun OF America, Inc.
824 Twelfth Ave.
P.O. Box 4027
Bethlehem,  PA  18018 -0027
Correspondent Contact CHRISTINE HARRIS
Regulation Number868.5150
Classification Product Code
BSP  
Subsequent Product Code
CAZ  
Date Received05/27/1993
Decision Date 01/26/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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