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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 K150473
Device Name FlexPointer 1.5 mm
Applicant
FIAGON GMBH
NEUENDORFSTR. 23B
HENNIGSDORF,  DE 16761
Applicant Contact DR. DIRK MUCHA
Correspondent
FIAGON GMBH
NEUENDORFSTR. 23B
HENNIGSDORF,  DE 16761
Correspondent Contact DR. DIRK MUCHA
Regulation Number882.4560
Classification Product Code
PGW  
Date Received02/23/2015
Decision Date 04/16/2015
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
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