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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Phacofragmentation
510(k) Number K871649
Device Name CLASSIC 70 LENS
Applicant
KOREA ASAHI OPTICAL CO., LTD.
135 WEST 27TH ST.
NEW YORK,  NY  10001
Applicant Contact MURRAY GREEN
Correspondent
KOREA ASAHI OPTICAL CO., LTD.
135 WEST 27TH ST.
NEW YORK,  NY  10001
Correspondent Contact MURRAY GREEN
Regulation Number886.4670
Classification Product Code
HQC  
Date Received04/29/1987
Decision Date 05/29/1987
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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