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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 K945770
Device Name OPTICAL FRAMES
Applicant
Ramada Optics, Inc.
22751 Suite E
Mandeville Pl.
Boca Raton,  FL  33433
Correspondent
Ramada Optics, Inc.
22751 Suite E
Mandeville Pl.
Boca Raton,  FL  33433
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received11/02/1994
Decision Date 12/15/1994
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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