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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ear, Nose, And Throat Stereotaxic Instrument
510(k) Number K243053
Device Name Navient Image Guided Navigation System (ENT) (955-NC-NC)
Applicant
Claronav
1140 Sheppard Ave. W. Unit 10
Toronto,  CA M3K 2A2
Applicant Contact Karen Wu
Correspondent
Claronav
1140 Sheppard Ave. W. Unit 10
Toronto,  CA M3K 2A2
Correspondent Contact Karen Wu
Regulation Number882.4560
Classification Product Code
PGW  
Date Received09/27/2024
Decision Date 06/20/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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