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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K073034
Device Name AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419)
Applicant
Applied Medical Technology, Inc.
15653 Neo Pkwy.
Cleveland,  OH  44128
Applicant Contact BRIAN BAKER
Correspondent
Applied Medical Technology, Inc.
15653 Neo Pkwy.
Cleveland,  OH  44128
Correspondent Contact BRIAN BAKER
Regulation Number876.5980
Classification Product Code
KNT  
Date Received10/26/2007
Decision Date 03/14/2008
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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