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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 K910951
Device Name OPTHLAMIC FRAMES
Applicant
United Optical, Spa
227 S. Philadelphia
P.O. Box 1147
Shawnee,  OK  74801
Applicant Contact DAVID JAMES
Correspondent
United Optical, Spa
227 S. Philadelphia
P.O. Box 1147
Shawnee,  OK  74801
Correspondent Contact DAVID JAMES
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received03/05/1991
Decision Date 05/06/1991
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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