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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Spectacle, Non-Custom (Prescription)
510(k) Number K854218
Device Name THE ULTRA-MATE LENS
Applicant
Optical Systems Intl., Inc.
1652 W. 32nd. Pl.
Hialeah,  FL  33012
Applicant Contact DE ROJAS
Correspondent
Optical Systems Intl., Inc.
1652 W. 32nd. Pl.
Hialeah,  FL  33012
Correspondent Contact DE ROJAS
Regulation Number886.5844
Classification Product Code
HQG  
Date Received10/17/1985
Decision Date 11/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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