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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonoscope And Accessories, Flexible/Rigid
510(k) Number K100624
Device Name INVENDO C20 COLONOSCOPY SYSTEM
Applicant
INVENDO MEDICAL GBMH
PETERHOFSTRAUSSE 3B
KISSING,  DE 86438
Applicant Contact OLIVER V RUEPPRECHT
Correspondent
INVENDO MEDICAL GBMH
PETERHOFSTRAUSSE 3B
KISSING,  DE 86438
Correspondent Contact OLIVER V RUEPPRECHT
Regulation Number876.1500
Classification Product Code
FDF  
Date Received03/04/2010
Decision Date 02/23/2012
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
Predetermined Change
Control Plan Authorized		 No
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