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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 K922258
Device Name SPECTACLE FRAMES
Applicant
British Optical Import Co.
375 Diablo Rd., Suite 107
Danville,  CA  94526
Applicant Contact G SIEGFRIED
Correspondent
British Optical Import Co.
375 Diablo Rd., Suite 107
Danville,  CA  94526
Correspondent Contact G SIEGFRIED
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received05/06/1992
Decision Date 09/02/1992
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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