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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 K900091
Device Name MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR
Applicant
Onufryk Low Vision Ent.
9 Wickford Way
Fairport,  NY  14450
Applicant Contact MICHAEL ONUFRYK
Correspondent
Onufryk Low Vision Ent.
9 Wickford Way
Fairport,  NY  14450
Correspondent Contact MICHAEL ONUFRYK
Regulation Number886.5844
Classification Product Code
HQG  
Date Received01/05/1990
Decision Date 04/04/1990
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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