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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Spectacle, Non-Custom (Prescription)
510(k) Number K851163
Device Name SUNGLASES
Applicant
Full See Glasses Ind. Co., Ltd.
7 Floor #38 Sec. 1, Fu Hsing S.R
Taipe, Taiwan,  TW
Applicant Contact PHILIP LIN
Correspondent
Full See Glasses Ind. Co., Ltd.
7 Floor #38 Sec. 1, Fu Hsing S.R
Taipe, Taiwan,  TW
Correspondent Contact PHILIP LIN
Regulation Number886.5844
Classification Product Code
HQG  
Date Received03/22/1985
Decision Date 05/30/1985
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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