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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 K192090
Device Name CMOS Video Rhino-Laryngoscope SSU
Applicant
Karl Storz SE & CO. KG
Dr.-Karl-Storz-Strasse 34
Tuttlingen,  DE 78532
Applicant Contact Alexey Davidov
Correspondent
Karl Storz SE & CO. KG
Dr.-Karl-Storz-Strasse 34
Tuttlingen,  DE 78532
Correspondent Contact Alexey Davidov
Regulation Number874.4760
Classification Product Code
EOB  
Subsequent Product Code
EOX  
Date Received08/05/2019
Decision Date 01/27/2020
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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