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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 K931648
Device Name SPECTACLE FRAMES
Applicant
Eye Care Centers of America, Inc.
Eye Care Plz.
11103 W. Ave.
San Antonio,  TX  78213
Applicant Contact MICHAEL MINOR
Correspondent
Eye Care Centers of America, Inc.
Eye Care Plz.
11103 W. Ave.
San Antonio,  TX  78213
Correspondent Contact MICHAEL MINOR
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received04/05/1993
Decision Date 08/05/1993
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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