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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 K941581
Device Name HAPPY EYES OPTICAL CO. SUNGLASSES
Applicant
Happy Eye Optical Co.
1211 Chimsan 1 Dong, Puk-Gu
Taegu,  KR 702-051
Applicant Contact S. M SHIM
Correspondent
Happy Eye Optical Co.
1211 Chimsan 1 Dong, Puk-Gu
Taegu,  KR 702-051
Correspondent Contact S. M SHIM
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/31/1994
Decision Date 07/25/1994
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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