BL-Cart IOL Delivery Cartridge

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 Bl-cart Iol Delivery Cartridge.

Pre-market Notification Details

Device IDK182965
510k NumberK182965
Device Name:BL-Cart IOL Delivery Cartridge
ClassificationFolders And Injectors, Intraocular Lens (iol)
Applicant AST Products, Inc. 9 Linnell Circle Billerica,  MA  01821
ContactWilliam Lee
CorrespondentWilliam Lee
Regulatory Doctor 9 Linnell Circle Billerica,  MA  01821
Product CodeMSS  
CFR Regulation Number886.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-25
Decision Date2019-03-29

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