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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 K220146
Device Name VisAR
Applicant
Novarad Corporation
3152 North University Avenue, Suite 200
Provo,  UT  84604
Applicant Contact Doug Merrill
Correspondent
Novarad Corporation
3152 North University Avenue, Suite 200
Provo,  UT  84604
Correspondent Contact Doug Merrill
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Code
LLZ  
Date Received01/19/2022
Decision Date 05/27/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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