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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 K063654
Device Name ENDOGUIDE
Applicant
KMS MEDICAL LLC
7290 SW 42ND STREET
MIAMI,  FL  33155
Applicant Contact MARIO ARBESU
Correspondent
KMS MEDICAL LLC
7290 SW 42ND STREET
MIAMI,  FL  33155
Correspondent Contact MARIO ARBESU
Regulation Number876.1500
Classification Product Code
FDF  
Subsequent Product Code
FED  
Date Received12/08/2006
Decision Date 01/31/2007
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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