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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Frame, Spectacle
510(k) Number K933074
Device Name SUNGLASSES
Applicant
P.T. Sun and Young Indonesia Sunglasses
Jl Bungur Besar Raya 85 / A3
Jakarta Pusat
Indonesia,  ID
Applicant Contact MICHAEL HSU
Correspondent
P.T. Sun and Young Indonesia Sunglasses
Jl Bungur Besar Raya 85 / A3
Jakarta Pusat
Indonesia,  ID
Correspondent Contact MICHAEL HSU
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received06/23/1993
Decision Date 09/20/1993
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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