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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name clip, implantable
510(k) Number K213813
Device Name DuraFuse Clip and Applier System
Applicant
NeuraMedica Inc
402 Beavercreek Road, Suite 110
Oregon City,  OR  97045
Applicant Contact Rachel Dreilinger
Correspondent
NeuraMedica Inc
402 Beavercreek Road, Suite 110
Oregon City,  OR  97045
Correspondent Contact Rachel Dreilinger
Regulation Number878.4300
Classification Product Code
FZP  
Date Received12/07/2021
Decision Date 07/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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