LIOLI IOL DELIVERY SYSTEM

Folders And Injectors, Intraocular Lens (iol)

AST PRODUCTS, INC.

The following data is part of a premarket notification filed by Ast Products, Inc. with the FDA for Lioli Iol Delivery System.

Pre-market Notification Details

Device IDK142056
510k NumberK142056
Device Name:LIOLI IOL DELIVERY SYSTEM
ClassificationFolders And Injectors, Intraocular Lens (iol)
Applicant AST PRODUCTS, INC. 9 Linnell Circle Billerica,  MA  01821
ContactWilliam Lee
CorrespondentDavid Lim
REGULATORY DOCTOR 3955 RINER ROAD, BOX148 Riner,  VA  24149
Product CodeMSS  
CFR Regulation Number886.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-29
Decision Date2015-04-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10814899027027 K142056 000
10814899027010 K142056 000
10814899027003 K142056 000

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