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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K160846
Device Name AmplifEYE
Applicant
MEDIVATORS, INC.
3150 POLLOK DR.
CONROE,  TX  77303
Applicant Contact Jeff Kasoff
Correspondent
MEDIVATORS INC.
14605 28TH AVE N
Minneapolis,  MN  55447
Correspondent Contact Kristin Bergeson Padilla
Regulation Number876.1500
Classification Product Code
FED  
Date Received03/28/2016
Decision Date 07/14/2016
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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