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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 K980305
Device Name AMT BUTTON REPLACEMENT GASTROSTOMY DEVICE
Applicant
Applied Medical Technology, Inc.
15653 Neo Pkwy.
Cleveland,  OH  44128
Applicant Contact THOMAS W PARKINSON
Correspondent
Applied Medical Technology, Inc.
15653 Neo Pkwy.
Cleveland,  OH  44128
Correspondent Contact THOMAS W PARKINSON
Regulation Number876.5980
Classification Product Code
KNT  
Date Received01/27/1998
Decision Date 04/16/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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