LENSTEC LC INJECTION SYSTEM

Folders And Injectors, Intraocular Lens (iol)

LENSTEC, INC.

The following data is part of a premarket notification filed by Lenstec, Inc. with the FDA for Lenstec Lc Injection System.

Pre-market Notification Details

Device IDK122848
510k NumberK122848
Device Name:LENSTEC LC INJECTION SYSTEM
ClassificationFolders And Injectors, Intraocular Lens (iol)
Applicant LENSTEC, INC. 1765 Commerce Ave N Saint Petersburg,  FL  33716
ContactJimmy Chacko
CorrespondentJohn Howlett
BSI HEALTHCARE KITEMARK COURT, DAVY AVENUE KNOWLHILL Milton Keynes,  GB Mk5 8pp
Product CodeMSS  
CFR Regulation Number886.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2012-09-18
Decision Date2013-10-18
Summary:summary

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