AOI LC-40 PHACOEMULSIFIER

Unit, Phacofragmentation

AMERICAN OPTISURGICAL, INC.

The following data is part of a premarket notification filed by American Optisurgical, Inc. with the FDA for Aoi Lc-40 Phacoemulsifier.

Pre-market Notification Details

Device IDK952331
510k NumberK952331
Device Name:AOI LC-40 PHACOEMULSIFIER
ClassificationUnit, Phacofragmentation
Applicant AMERICAN OPTISURGICAL, INC. 19 HAMMOND SUITE 505 Irvine,  CA  92718
ContactGlenn A Dunki-jacobs
CorrespondentGlenn A Dunki-jacobs
AMERICAN OPTISURGICAL, INC. 19 HAMMOND SUITE 505 Irvine,  CA  92718
Product CodeHQC  
CFR Regulation Number886.4670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-18
Decision Date1995-08-16

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