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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 K170335
Device Name Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens
Applicant
Valley Contax, Inc.
200 S. Mill St.
Springfield,  OR  97477
Applicant Contact Josh Adams
Correspondent
Eyereg Consulting, Inc.
6119 Canter Ln.
West Linn,  OR  97068
Correspondent Contact Bret Andre
Regulation Number886.5916
Classification Product Code
HQD  
Date Received02/02/2017
Decision Date 03/24/2017
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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