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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 K935943
Device Name KING'S SUNGLASS CORP.
Applicant
King'S Sunglass Corp.
2535 N. Durfee Ave.
El Monte,  CA  91732
Applicant Contact JEAN LIN
Correspondent
King'S Sunglass Corp.
2535 N. Durfee Ave.
El Monte,  CA  91732
Correspondent Contact JEAN LIN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received12/13/1993
Decision Date 04/19/1994
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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