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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 K871961
Device Name MULTIPLE SPECTACLE LENS
Applicant
Korea Asahi Optical Co., Ltd.
514-18 Shinsa-Dong
Gangnam-Gu
Seoul, Korea,  KR
Applicant Contact YOON, SOO-HAN
Correspondent
Korea Asahi Optical Co., Ltd.
514-18 Shinsa-Dong
Gangnam-Gu
Seoul, Korea,  KR
Correspondent Contact YOON, SOO-HAN
Regulation Number886.5844
Classification Product Code
HQG  
Date Received05/20/1987
Decision Date 06/03/1987
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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