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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name telescope, spectacle, low-vision
510(k) Number K864594
Device Name DUALENZ LOW VISION EYEWEAR
Original Applicant
GLOBAL EYE CARE, INC.
2133 buffalo rd.
rochester,  NY  14624
Original Contact james c bradford
Regulation Number886.5870
Classification Product Code
HKK  
Date Received11/21/1986
Decision Date 01/20/1987
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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