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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 K941873
Device Name SUNGLASSES
Applicant
Koadak Optical Industrial Co., Ltd.
1f. # 21, Ln. 49, Sec. 4
Chung Ching N. Rd.
Taipei,  TW
Applicant Contact JEFFERSON SHIEH
Correspondent
Koadak Optical Industrial Co., Ltd.
1f. # 21, Ln. 49, Sec. 4
Chung Ching N. Rd.
Taipei,  TW
Correspondent Contact JEFFERSON SHIEH
Regulation Number886.5850
Classification Product Code
HQY  
Date Received04/18/1994
Decision Date 06/03/1994
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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