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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 K897090
Device Name SUNGLASSES
Applicant
Pt Midas Surya Optical Co.
Jl. Rawa Sumur Barat # 1
Industrial Estate Pulogadung
Jakarta 13930 Indonesia,  ID
Applicant Contact IL KIM
Correspondent
Pt Midas Surya Optical Co.
Jl. Rawa Sumur Barat # 1
Industrial Estate Pulogadung
Jakarta 13930 Indonesia,  ID
Correspondent Contact IL KIM
Regulation Number886.5850
Classification Product Code
HQY  
Date Received12/20/1989
Decision Date 08/28/1990
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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