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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 K133632
Device Name PERICAN ULTRA
Applicant
B.Braun Medical, Inc.
901 Marcon Blvd.
Allentown,  PA  18109
Applicant Contact LISA GIAQUINTO
Correspondent
B.Braun Medical, Inc.
901 Marcon Blvd.
Allentown,  PA  18109
Correspondent Contact LISA GIAQUINTO
Regulation Number868.5150
Classification Product Code
BSP  
Date Received11/26/2013
Decision Date 06/27/2014
Decision Substantially Equivalent (SESE)
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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