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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 K945341
Device Name MULTIPLE
Applicant
Mi MI Progress Co. , Ltd.
4th Floor, Mi M Bldg.
#1259-5, Chim San 1 Don
Buk-Gu, Daegu,  KR 213
Applicant Contact J J ROH
Correspondent
Mi MI Progress Co. , Ltd.
4th Floor, Mi M Bldg.
#1259-5, Chim San 1 Don
Buk-Gu, Daegu,  KR 213
Correspondent Contact J J ROH
Regulation Number886.5850
Classification Product Code
HQY  
Date Received11/01/1994
Decision Date 12/07/1994
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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