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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 K926157
Device Name EYEGLASS FRAME
Applicant
Roi Factory Direct Frame Co.
3702 E. Roeser Rd.
Suite 16
Phoenix,  AR  85040
Applicant Contact CHRISTY L SCHUMAR
Correspondent
Roi Factory Direct Frame Co.
3702 E. Roeser Rd.
Suite 16
Phoenix,  AR  85040
Correspondent Contact CHRISTY L SCHUMAR
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received12/08/1992
Decision Date 05/06/1993
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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