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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Nephroscope
510(k) Number K151308
Device Name Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set
Applicant
Schoelly Fiberoptic GmbH
Robert-Bosch-Str. 1-3
Denzlingen,  DE 79211
Applicant Contact SANDRA BAUMANN
Correspondent
Schoelly Fiberoptic GmbH
Robert-Bosch-Str. 1-3
Denzlingen,  DE 79211
Correspondent Contact SANDRA BAUMANN
Regulation Number876.1500
Classification Product Code
FGA  
Subsequent Product Codes
FEC   FED  
Date Received05/18/2015
Decision Date 02/09/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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