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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 K043027
Device Name MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20
Applicant
Applied Medical Technology, Inc.
15653 Neo Pkwy.
Cleveland,  OH  44128
Applicant Contact DEREK WILLIAMS
Correspondent
Applied Medical Technology, Inc.
15653 Neo Pkwy.
Cleveland,  OH  44128
Correspondent Contact DEREK WILLIAMS
Regulation Number876.5980
Classification Product Code
KNT  
Date Received11/03/2004
Decision Date 12/02/2004
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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