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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name snare, flexible
510(k) Number K924105
Device Name SNARE FLEXIBLE
Applicant
UNITED STATES ENDOSCOPY GROUP, INC.
7123 INDUSTRIAL PARK BLVD.
MENTOR,  OH  44060
Applicant Contact MARLIN YOUNKER
Correspondent
UNITED STATES ENDOSCOPY GROUP, INC.
7123 INDUSTRIAL PARK BLVD.
MENTOR,  OH  44060
Correspondent Contact MARLIN YOUNKER
Regulation Number876.4300
Classification Product Code
FDI  
Date Received08/13/1992
Decision Date 11/24/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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