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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Gastro-Enterostomy
510(k) Number K980145
Device Name AMT DECOMPRESSION TUBES
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
KGC  
Date Received01/15/1998
Decision Date 04/10/1998
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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