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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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