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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 K883226
Device Name OPTICAL OR EYEGLASS FRAME
Applicant
Unique Optic , Ltd.
C/O Kaplan Russin & Vecchi
1215 Seventeenth St., NW
Washington,  DC  20036
Applicant Contact BRUCE M LANDAY
Correspondent
Unique Optic , Ltd.
C/O Kaplan Russin & Vecchi
1215 Seventeenth St., NW
Washington,  DC  20036
Correspondent Contact BRUCE M LANDAY
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received08/01/1988
Decision Date 08/24/1988
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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