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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Frame, Spectacle
510(k) Number K920181
Device Name OPTICAL FRAME A285, A210, B220, A215, A255, B220,
Applicant
Kentucky Optical Co.
638-40 S. Fourth St.
Louisville,  KY  40202
Applicant Contact BEAU BOWLES
Correspondent
Kentucky Optical Co.
638-40 S. Fourth St.
Louisville,  KY  40202
Correspondent Contact BEAU BOWLES
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received01/15/1992
Decision Date 04/15/1992
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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