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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ent Manual Surgical
510(k) Number K201472
Device Name VenSure Balloon Device, VenSure Nav Balloon Device
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 Number874.4420
Classification Product Code
LRC  
Date Received06/03/2020
Decision Date 08/26/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
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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