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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, Mechanical, Gastrointestinal
510(k) Number K984168
Device Name BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE
Applicant
United States Endoscopy Group, Inc.
5976 Heisley Rd.
Mentor,  OH  44060
Applicant Contact DEAN SECREST
Correspondent
United States Endoscopy Group, Inc.
5976 Heisley Rd.
Mentor,  OH  44060
Correspondent Contact DEAN SECREST
Regulation Number876.1075
Classification Product Code
FCF  
Date Received11/20/1998
Decision Date 12/07/1999
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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