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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 K944783
Device Name SUN EYEWEAR COMPANY, MULTIPLE BRAND NAMES
Applicant
Sun Eyewear Co.
1-93 Wol Am-Dong, Dalseo-Ku
Sungseo Industrial Complex
Daegu,  KR
Applicant Contact HUNYANG PARK
Correspondent
Sun Eyewear Co.
1-93 Wol Am-Dong, Dalseo-Ku
Sungseo Industrial Complex
Daegu,  KR
Correspondent Contact HUNYANG PARK
Regulation Number886.5850
Classification Product Code
HQY  
Date Received09/27/1994
Decision Date 10/27/1994
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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