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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 K974414
Device Name MULTI
Applicant
Morning Calm Corp.
1106 Seong An Officetel
87-36, Duryu-2dong,Dalseo-Gu
Daegu,  KR
Applicant Contact ALEXANDER B KIM
Correspondent
Morning Calm Corp.
1106 Seong An Officetel
87-36, Duryu-2dong,Dalseo-Gu
Daegu,  KR
Correspondent Contact ALEXANDER B KIM
Regulation Number886.5850
Classification Product Code
HQY  
Date Received11/24/1997
Decision Date 12/08/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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