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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 K915783
Device Name S.A.A. EYE GLASS FRAMES
Applicant
Yau Yee Optical Co., Ltd.
9131 King Arthur Dr.
Dallas,  TX  75247
Applicant Contact ROBERT GRANOFF
Correspondent
Yau Yee Optical Co., Ltd.
9131 King Arthur Dr.
Dallas,  TX  75247
Correspondent Contact ROBERT GRANOFF
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received12/24/1991
Decision Date 02/27/1992
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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