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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 K914766
Device Name SUN SIGHT SUNGLASSES/SUN SIGHT READING GLASSES
Applicant
Sun Sight Glasses Co., Ltd.
P.O. Box 892, #25, Ln. 150,
Section 2, An Hod Rd. Tainan,
Taiwan R.O.C.,  CN
Applicant Contact JOEY LEE
Correspondent
Sun Sight Glasses Co., Ltd.
P.O. Box 892, #25, Ln. 150,
Section 2, An Hod Rd. Tainan,
Taiwan R.O.C.,  CN
Correspondent Contact JOEY LEE
Regulation Number886.5850
Classification Product Code
HQY  
Date Received10/22/1991
Decision Date 01/17/1992
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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