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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 K963059
Device Name SUNQUEST INTERNATIONAL
Applicant
Sunquest Intl., Inc.
8-1 Chung-Hsiao E. Rd., 1/F,
Aly. 16, Ln. 553, Sec. 4
Taipei,  TW
Applicant Contact MINGNA CHIU
Correspondent
Sunquest Intl., Inc.
8-1 Chung-Hsiao E. Rd., 1/F,
Aly. 16, Ln. 553, Sec. 4
Taipei,  TW
Correspondent Contact MINGNA CHIU
Regulation Number886.5850
Classification Product Code
HQY  
Date Received08/02/1996
Decision Date 08/23/1996
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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