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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 K211291
Device Name Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D
Applicant
Fiagon GmbH
Neuendorfstr. 23b
Hennigsdorf,  DE 16761
Applicant Contact Dirk Mucha
Correspondent
Fiagon GmbH
Neuendorfstr. 23b
Hennigsdorf,  DE 16761
Correspondent Contact Dirk Mucha
Regulation Number882.4560
Classification Product Code
PGW  
Date Received04/28/2021
Decision Date 07/19/2021
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
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