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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 K935605
Device Name SPECTACLE FRAMES
Applicant
Sovereign Eyewear, Inc.
690 Market St.
Suite 930
San Francisco,  CA  94104
Applicant Contact IRENE SUM
Correspondent
Sovereign Eyewear, Inc.
690 Market St.
Suite 930
San Francisco,  CA  94104
Correspondent Contact IRENE SUM
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received11/19/1993
Decision Date 02/16/1994
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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