Bioli LOL 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 Bioli Lol Delivery System.

Pre-market Notification Details

Device IDK200057
510k NumberK200057
Device Name:Bioli LOL Delivery System
ClassificationFolders And Injectors, Intraocular Lens (iol)
Applicant AST Products, Inc. 9 Linnell Circle Billerica,  MA  01821
ContactWilliam Lee
CorrespondentWilliam Lee
AST Products, Inc. 9 Linnell Circle Billerica,  MA  01821
Product CodeMSS  
CFR Regulation Number886.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-13
Decision Date2020-06-04

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.