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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 K142510
Device Name UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact Lens
Applicant
Synergeyes, Inc.
2232 Rutherford Road
Carlsbad,  CA  92008
Applicant Contact Steven L. Ziemba
Correspondent
Synergeyes, Inc.
2232 Rutherford Road
Carlsbad,  CA  92008
Correspondent Contact Steven L. Ziemba
Regulation Number886.5916
Classification Product Code
HQD  
Date Received09/08/2014
Decision Date 11/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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