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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 K113050
Device Name CLEARPATH LOWER GI
Applicant
EASYGLIDE LTD.
24301 WOODSAGE DR.
BONITA SPRINGS,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
EASYGLIDE LTD.
24301 WOODSAGE DR.
BONITA SPRINGS,  FL  34134
Correspondent Contact PAUL DRYDEN
Regulation Number876.1500
Classification Product Code
FDF  
Date Received10/13/2011
Decision Date 05/16/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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