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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nasopharyngoscope (Flexible Or Rigid)
510(k) Number K153701
Device Name ULYSS Multi View Sinuscope
Applicant
SOPRO-COMEG GMBH
DORNIERSTRASSE 55
TUTTLINGEN,  DE 78532
Applicant Contact HAROLD LETTAU
Correspondent
BUSINESS SUPPORT INTERNATIONAL
AMSTEL 320-1
AMSTERDAM,  NL 1017AP
Correspondent Contact ANGELIKA SCHERP
Regulation Number874.4760
Classification Product Code
EOB  
Date Received12/23/2015
Decision Date 09/09/2016
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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