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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vascular, For Promoting Embolization
510(k) Number K192083
Device Name Okami Medical LOBO Vascular Occlusion System
Applicant
Okami Medical
8 Argonaut
Suite 100
Aliso Viejo,  CA  92656
Applicant Contact Rebecca K Pine
Correspondent
Okami Medical
8 Argonaut
Suite 100
Aliso Viejo,  CA  92656
Correspondent Contact Rebecca K Pine
Regulation Number870.3300
Classification Product Code
KRD  
Date Received08/02/2019
Decision Date 10/30/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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