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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spectacle, magnifying
510(k) Number K854854
Device Name SYSTEMS OF SIGHT LOW VISION EYEWARE
Applicant
INT'L EYE CARE, INC.
67 CHESTNUT ST, STE 425
ROCHESTER,  NY  14604
Applicant Contact JAMES C BRADFORD
Correspondent
INT'L EYE CARE, INC.
67 CHESTNUT ST, STE 425
ROCHESTER,  NY  14604
Correspondent Contact JAMES C BRADFORD
Regulation Number886.5840
Classification Product Code
HOI  
Date Received12/05/1985
Decision Date 02/04/1986
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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