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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 K933529
Device Name EYEGLASSES FRAMES
Applicant
Vistula Assistance & Consulting Bureau
4800 N.Milwaukee Ave.
Suite 207
Chicago,  IL  60630
Applicant Contact BARBARA ORALEWSKA
Correspondent
Vistula Assistance & Consulting Bureau
4800 N.Milwaukee Ave.
Suite 207
Chicago,  IL  60630
Correspondent Contact BARBARA ORALEWSKA
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received07/20/1993
Decision Date 10/20/1993
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
Recalls CDRH Recalls
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