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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 K933280
Device Name SPECTACLE FRAMES
Applicant
U.S. Optical
2351 NW 93rd Ave.
Miami,  FL  33172
Applicant Contact LORRAINE CASON
Correspondent
U.S. Optical
2351 NW 93rd Ave.
Miami,  FL  33172
Correspondent Contact LORRAINE CASON
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received07/06/1993
Decision Date 08/31/1993
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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