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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 K121582
Device Name INVENDO C25 COLONOSCOPY SYSTEM
Applicant
INVENDO MEDICAL GBMH
peterhofstr. 3b
kissing, 
Contact oliver v ruepprecht
Regulation Number876.1500
Classification Product Code
FDF  
Date Received05/30/2012
Decision Date 12/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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