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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 K871689
Device Name SPECTACLE FRAME - LORRAINE
Applicant
Roseburg SA
Suite 120 Canal Sq.
1054 31st St. NW
Washington,  DC  20007
Applicant Contact DARIENNE MOYER
Correspondent
Roseburg SA
Suite 120 Canal Sq.
1054 31st St. NW
Washington,  DC  20007
Correspondent Contact DARIENNE MOYER
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received04/29/1987
Decision Date 05/29/1987
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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