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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K890629
Device Name ESOPHAGEAL OVERTUBE
Applicant
Gastrotech, Inc.
6551 Brecksville Rd.
Independence,  OH  44131
Applicant Contact PAT GILPIN
Correspondent
Gastrotech, Inc.
6551 Brecksville Rd.
Independence,  OH  44131
Correspondent Contact PAT GILPIN
Regulation Number876.1500
Classification Product Code
FED  
Date Received02/10/1989
Decision Date 05/31/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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