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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 K934567
Device Name SUNGLASSES (NON-PERSCRIPTION)
Applicant
Jaan Huey Co., Ltd.
9f-10, # 472
Chang Shan 2nd Rd.
Kaohsiung, Taiwan,  TW
Applicant Contact LEE J LIN
Correspondent
Jaan Huey Co., Ltd.
9f-10, # 472
Chang Shan 2nd Rd.
Kaohsiung, Taiwan,  TW
Correspondent Contact LEE J LIN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received09/16/1993
Decision Date 03/24/1994
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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