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510(k) K161232

ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit by Halyard Health — Product Code BSO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2016
Date Received
May 2, 2016
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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