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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
Applicant
GLOBAL EYE CARE, INC.
2133 BUFFALO RD.
ROCHESTER,  NY  14624
Applicant Contact JAMES C BRADFORD
Correspondent
GLOBAL EYE CARE, INC.
2133 BUFFALO RD.
ROCHESTER,  NY  14624
Correspondent 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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