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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 K202539
Device Name Nutriglide(TM) Nasal Feeding Tube
Applicant
Applied Medical Technology, Inc.
8006 Katherine Blvd.
Brecksville,  OH  44141
Applicant Contact Joy Tubero
Correspondent
Applied Medical Technology, Inc.
8006 Katherine Blvd.
Brecksville,  OH  44141
Correspondent Contact Joy Tubero
Regulation Number876.5980
Classification Product Code
KNT  
Date Received09/02/2020
Decision Date 10/29/2020
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
Recalls CDRH Recalls
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