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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 K161355
Device Name invendoscopy E200 System
Applicant
Invendo Medical GmbH
Peterhofstr. 3b
Kissing,  DE 86438
Applicant Contact Oliver V. Ruepprecht
Correspondent
Invendo Medical GmbH
Peterhofstr. 3b
Kissing,  DE 86438
Correspondent Contact Oliver V. Ruepprecht
Regulation Number876.1500
Classification Product Code
FDF  
Date Received05/16/2016
Decision Date 08/25/2016
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
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