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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 K930956
Device Name SIGMA-BRILLEN (OR) MULTIPLE
Applicant
Sigma-Brillen
3980 Glenfeliz Blvd.
Los Angeles,  CA  90030
Correspondent
Sigma-Brillen
3980 Glenfeliz Blvd.
Los Angeles,  CA  90030
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received02/23/1993
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
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