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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, conduction, anesthetic
510(k) Number K153297
Device Name Perifix and Contiplex Catheter
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 Number868.5120
Classification Product Code
BSO  
Date Received11/13/2015
Decision Date 08/12/2016
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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