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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Conduction, Anesthetic (W/Wo Introducer)
510(k) Number K151072
Device Name Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit
Applicant
Solo-Dex, Inc.
3 Moonlight Isle
Ladera Ranch,  CA  92694
Applicant Contact Siddarth Desai
Correspondent
ALBERT REGO, PH.D.
27001 LA PAZ ROAD, SUITE 312
MISSION VIEJO,  CA  92691
Correspondent Contact Albert Rego
Regulation Number868.5150
Classification Product Code
BSP  
Date Received04/21/2015
Decision Date 01/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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