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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sunglasses (Non-Prescription Including Photosensitive)
510(k) Number K932941
Device Name SUNGLASSES
Applicant
Rayman Speco Co., Ltd.
455, Chien Kang Rd., P.O.
Box 326
Tainan,  TW
Applicant Contact THOMAS LIN
Correspondent
Rayman Speco Co., Ltd.
455, Chien Kang Rd., P.O.
Box 326
Tainan,  TW
Correspondent Contact THOMAS LIN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received06/16/1993
Decision Date 09/20/1993
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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