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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Telescope, Rigid, Endoscopic
510(k) Number K151191
Device Name OES ELITE Telescopes, Protective Tube
Applicant
Olympus Winter &Ibe GmbH
Kuehnestrasse 61
Hamburg,  DE 22045
Applicant Contact KATHARINA SCHNACKENBURG
Correspondent
Olympus Corporation of the Americas
3500 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact DAPHNEY GERMAIN-KOLAWOLE
Regulation Number876.1500
Classification Product Code
FBP  
Subsequent Product Codes
FGC   HIH  
Date Received05/04/2015
Decision Date 11/24/2015
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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