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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 K012476
Device Name MONARCH, TRANSSHAPING GASTROSTOMY TUBE MODEL 9-2010
Applicant
APPLIED MEDICAL TECHNOLOGY, INC.
15653 NEO PKWY.
CLEVELAND,  OH  44128
Applicant Contact CHRIS ZANTOPULOS
Correspondent
APPLIED MEDICAL TECHNOLOGY, INC.
15653 NEO PKWY.
CLEVELAND,  OH  44128
Correspondent Contact CHRIS ZANTOPULOS
Regulation Number876.5980
Classification Product Code
KNT  
Date Received08/02/2001
Decision Date 08/31/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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