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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 K944484
Device Name KODI OPTICAL CO., LTD. SUNGLASSES
Applicant
Kodi Optical Co. , Ltd.
#5 Aly. 17 Ln. 2 Ta-Ho
Taichung,  TW
Applicant Contact JAMES L CHEN
Correspondent
Kodi Optical Co. , Ltd.
#5 Aly. 17 Ln. 2 Ta-Ho
Taichung,  TW
Correspondent Contact JAMES L CHEN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received09/13/1994
Decision Date 11/10/1994
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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