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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
Valley Contax, Inc.
200 S Mill St
Springfield,  OR  97477
Applicant Contact Josh Adams
EyeReg Consulting, Inc.
6119 Canter Ln.
West Linn,  OR  97068
Correspondent Contact Bret Andre
Regulation Number886.5916
Classification Product Code
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