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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 K160479
Device Name PointerShell Universal, PointerShell LS
Applicant
FIAGON GMBH
NEUENDORFSTR. 23 B
HENNIGSDORF,  DE 16761
Applicant Contact DIRK MUCHA
Correspondent
FIAGON GMBH
NEUENDORFSTR. 23 B
HENNIGSDORF,  DE 16761
Correspondent Contact DIRK MUCHA
Regulation Number882.4560
Classification Product Code
PGW  
Date Received02/22/2016
Decision Date 03/23/2016
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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