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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Injection Needle, Gastroenterology-Urology
510(k) Number K924102
Device Name NEEDLE
Applicant
UNITED STATES ENDOSCOPY GROUP, INC.
9905 HOBART RD.
WAITE HILL,  OH  44094
Applicant Contact MARLIN YOUNKER
Correspondent
UNITED STATES ENDOSCOPY GROUP, INC.
9905 HOBART RD.
WAITE HILL,  OH  44094
Correspondent Contact MARLIN YOUNKER
Regulation Number876.1500
Classification Product Code
FBK  
Date Received08/13/1992
Decision Date 11/25/1992
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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