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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 K941307
Device Name SPECTACLE FRAMES
Applicant
Eyemart Express, Inc.
1325 Capital Center Pkwy.
Suite 130
Carrollton,  TX  75006
Applicant Contact DEBRA WEBER
Correspondent
Eyemart Express, Inc.
1325 Capital Center Pkwy.
Suite 130
Carrollton,  TX  75006
Correspondent Contact DEBRA WEBER
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received03/17/1994
Decision Date 05/17/1994
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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