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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name endoscope and/or accessories
510(k) Number K112698
Device Name CONCENTRIC BALLOON GOOGLE
Original Applicant
UNITED STATES ENDOSCOPY GROUP, INC.
5976 heisley rd.
mentor,  OH  44060
Original Contact carroll l martin
Regulation Number876.1500
Classification Product Code
KOG  
Subsequent Product Code
ODC  
Date Received09/16/2011
Decision Date 05/18/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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