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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 K100241
Device Name CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680
Applicant
B. Braun Medical, Inc.
901 Marcon Blvd.
Allentown,  PA  18109 -9341
Applicant Contact LISA GIAQUINTO
Correspondent
B. Braun Medical, Inc.
901 Marcon Blvd.
Allentown,  PA  18109 -9341
Correspondent Contact LISA GIAQUINTO
Regulation Number868.5150
Classification Product Code
BSP  
Date Received01/27/2010
Decision Date 04/16/2010
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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