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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 K171673
Device Name Focus Cap
Applicant
GCE Medical Corporation
2723 West Tenaya
Fresno,  CA  93711
Applicant Contact Stanley Chang
Correspondent
MedReg Associates Inc.
228 Hull Cove Farm Road
Jamestown,  RI  02835
Correspondent Contact Stephen Page
Regulation Number876.1500
Classification Product Code
FDF  
Date Received06/06/2017
Decision Date 01/19/2018
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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