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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 K790251
Device Name FUL-VUE ASPHERIC CATARACT LENS
Applicant
American Optical Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Optical Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number886.5844
Classification Product Code
HQG  
Date Received02/06/1979
Decision Date 02/26/1979
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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