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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biopsy Needle
510(k) Number K971842
Device Name COAXIAL NEEDLE
Applicant
UNITED STATES ENDOSCOPY GROUP, INC.
9330 PROGRESS PKWY.
MENTOR,  OH  44060
Applicant Contact GRETCHEN Y COHEN
Correspondent
UNITED STATES ENDOSCOPY GROUP, INC.
9330 PROGRESS PKWY.
MENTOR,  OH  44060
Correspondent Contact GRETCHEN Y COHEN
Regulation Number876.1075
Classification Product Code
FCG  
Date Received05/19/1997
Decision Date 06/20/1997
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
Recalls CDRH Recalls
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