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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 K854343
Device Name SIOM
Applicant
South West Intl., Inc.
Eyewear Distributors
1005-B Downtowner Blvd.
Mobile,  AL  36609
Applicant Contact ELIZABETH BURNES
Correspondent
South West Intl., Inc.
Eyewear Distributors
1005-B Downtowner Blvd.
Mobile,  AL  36609
Correspondent Contact ELIZABETH BURNES
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received10/29/1985
Decision Date 11/12/1985
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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