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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Analysis, Anterior Segment
510(k) Number K191051
Device Name ARGOS
Applicant
Santec Corporation
5823 Ohkusa-Nenjozaka
Komaki,  JP 485-0802
Applicant Contact Changho Chong
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact DAVE YUNGVIRT
Regulation Number886.1850
Classification Product Code
MXK  
Subsequent Product Code
HJO  
Date Received04/19/2019
Decision Date 05/16/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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