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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastroscope And Accessories, Flexible/Rigid
510(k) Number K130148
FOIA Releasable 510(k) K130148
Device Name FOREIGN BODY HOOD
Applicant
United States Endoscopy Group, Inc.
5976 Heisley Rd.
Mentor,  OH  44060
Applicant Contact CARROLL MARTIN
Correspondent
United States Endoscopy Group, Inc.
5976 Heisley Rd.
Mentor,  OH  44060
Correspondent Contact CARROLL MARTIN
Regulation Number876.1500
Classification Product Code
FDS  
Date Received01/22/2013
Decision Date 08/07/2013
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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