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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 K910415
Device Name SUNGLASSES
Applicant
K.M Optical Co.
Kyunguk R.C.O Box 95
Daegu
Korea,  KR
Applicant Contact LEE
Correspondent
K.M Optical Co.
Kyunguk R.C.O Box 95
Daegu
Korea,  KR
Correspondent Contact LEE
Regulation Number886.5850
Classification Product Code
HQY  
Date Received01/30/1991
Decision Date 05/01/1991
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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