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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 K914413
Device Name SPECTACLE FRAMES
Applicant
Mikado Ca.
1200 Pch #408
Hunting Beach,  CA  92648
Applicant Contact BEATE BRUDER
Correspondent
Mikado Ca.
1200 Pch #408
Hunting Beach,  CA  92648
Correspondent Contact BEATE BRUDER
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received10/03/1991
Decision Date 12/31/1991
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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