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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 K113059
Device Name CONTIPLEX FX
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 Number868.5140
Classification Product Code
CAZ  
Date Received10/14/2011
Decision Date 01/24/2012
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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