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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, neurovascular embolization
510(k) Number K173711
Device Name Wallaby Avenir Coil System
Applicant
Wallaby Medical, Inc.
23181 Verdugo Dr.
Laguna Hills,  CA  92653
Applicant Contact Rebecca K. Pine
Correspondent
Wallaby Medical, Inc.
23181 Verdugo Dr.
Laguna Hills,  CA  92653
Correspondent Contact Rebecca K. Pine
Regulation Number882.5950
Classification Product Code
HCG  
Date Received12/04/2017
Decision Date 05/04/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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