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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name instrument, biopsy, suction
510(k) Number K051637
Device Name DSNARE, MODEL 00711087
Applicant
UNITED STATES ENDOSCOPY GROUP, INC.
5976 HEISLEY RD.
MENTOR,  OH  44060
Applicant Contact GRETCHEN Y COHEN
Correspondent
UNITED STATES ENDOSCOPY GROUP, INC.
5976 HEISLEY RD.
MENTOR,  OH  44060
Correspondent Contact GRETCHEN Y COHEN
Regulation Number876.1075
Classification Product Code
FCK  
Subsequent Product Code
FDI  
Date Received06/20/2005
Decision Date 10/31/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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