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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 K113062
Device Name ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES
Applicant
ENDOSERVICE OPTICAL INSTRUMENTS GMBH
SCHWARZWALDSTRASSE 5
TUTTLINGEN,  DE 78532
Applicant Contact ANDREA PECSI
Correspondent
ENDOSERVICE OPTICAL INSTRUMENTS GMBH
SCHWARZWALDSTRASSE 5
TUTTLINGEN,  DE 78532
Correspondent Contact ANDREA PECSI
Regulation Number876.1500
Classification Product Code
FBP  
Date Received10/14/2011
Decision Date 08/21/2012
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
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