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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 K170319
Device Name Low Profile Non-Balloon Feeding Device
Applicant
APPLIED MEDICAL TECHNOLOGY INC.
8006 KATHERINE BOULEVARD
BRECKSVILLE,  OH  44141
Applicant Contact SHRADDHA SAINI
Correspondent
APPLIED MEDICAL TECHNOLOGY INC.
8006 KATHERINE BOULEVARD
BRECKSVILLE,  OH  44141
Correspondent Contact SHRADDHA SAINI
Regulation Number876.5980
Classification Product Code
KNT  
Date Received02/01/2017
Decision Date 10/06/2017
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
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