CLASSIC 70 LENS

Unit, Phacofragmentation

KOREA ASAHI OPTICAL CO., LTD.

The following data is part of a premarket notification filed by Korea Asahi Optical Co., Ltd. with the FDA for Classic 70 Lens.

Pre-market Notification Details

Device IDK871649
510k NumberK871649
Device Name:CLASSIC 70 LENS
ClassificationUnit, Phacofragmentation
Applicant KOREA ASAHI OPTICAL CO., LTD. 135 WEST 27TH ST. New York,  NY  10001
ContactMurray Green
CorrespondentMurray Green
KOREA ASAHI OPTICAL CO., LTD. 135 WEST 27TH ST. New York,  NY  10001
Product CodeHQC  
CFR Regulation Number886.4670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-04-29
Decision Date1987-05-29

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