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510(k) K171584

B. Braun Tear-Away Introducer Needle by B.Braun Medical, Inc. — Product Code BSO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2017
Date Received
May 31, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Conduction, Anesthetic
Device Class
Class II
Regulation Number
868.5120
Review Panel
AN
Submission Type

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