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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 K970356
Device Name IRRIGATION/ASPIRATION POLYPECTOMY
Applicant
UNITED STATES ENDOSCOPY GROUP, INC.
9300 PROGRESS PKWY.
MENTOR,  OH  44060
Applicant Contact GRETCHEN R YOUNKER
Correspondent
UNITED STATES ENDOSCOPY GROUP, INC.
9300 PROGRESS PKWY.
MENTOR,  OH  44060
Correspondent Contact GRETCHEN R YOUNKER
Regulation Number876.4300
Classification Product Code
FDI  
Date Received01/30/1997
Decision Date 03/25/1997
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
Predetermined Change
Control Plan Authorized		 No
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