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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 K171584
Device Name B. Braun Tear-Away Introducer Needle
Applicant
B. Braun Medical Inc.
901 Marcon Blvd.
Allentown,  PA  18109
Applicant Contact Kimberly Smith
Correspondent
B. Braun Medical Inc.
901 Marcon Blvd.
Allentown,  PA  18109
Correspondent Contact Kimberly Smith
Regulation Number868.5120
Classification Product Code
BSO  
Date Received05/31/2017
Decision Date 12/22/2017
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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