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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Contact (Other Material) - Daily
510(k) Number K160938
Device Name SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens
Applicant
Synergeyes, Inc.
5927 Priestly Dr., Suite210
Carlsbad,  CA  92008
Applicant Contact James Kirchner
Correspondent
Eyereg Consulting, Inc.
6119 Canter Ln.
West Linn,  OR  97068
Correspondent Contact Bret Andre
Regulation Number886.5916
Classification Product Code
HQD  
Date Received04/04/2016
Decision Date 08/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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