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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthopedic stereotaxic instrument
510(k) Number K223927
Device Name 360CAS
Applicant
Kico Knee Innovation Company Pty Limited
Suite 3, Building 1, 20 Bridge Street, Pymble NSW
Sydney,  AU 2073
Applicant Contact Danyon Munro
Correspondent
Kico Knee Innovation Company Pty Limited
Suite 3, Building 1, 20 Bridge Street, Pymble NSW
Sydney,  AU 2073
Correspondent Contact Danyon Munro
Regulation Number882.4560
Classification Product Code
OLO  
Date Received12/30/2022
Decision Date 01/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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