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510(k) K192083

Okami Medical LOBO Vascular Occlusion System by Okami Medical — Product Code KRD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2019
Date Received
August 2, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Vascular, For Promoting Embolization
Device Class
Class II
Regulation Number
870.3300
Review Panel
CV
Submission Type

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