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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 K200041
Device Name FlexPointer 1.5 Single Use, FlexTube 3 Single Use
Fiagon GmbH
Neuendorfstrasse 23b
Hennigsdorf,  DE 16761
Applicant Contact Dirk Mucha
Fiagon GmbH
Neuendorfstrasse 23b
Hennigsdorf,  DE 16761
Correspondent Contact Dirk Mucha
Regulation Number882.4560
Classification Product Code
Date Received01/08/2020
Decision Date 03/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No