LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES

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 Intraocular Lens (iol) Injection System For Tetraflex Intraocular Lenses.

Pre-market Notification Details

Device IDK050638
510k NumberK050638
Device Name:LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES
ClassificationFolders And Injectors, Intraocular Lens (iol)
Applicant LENSTEC, INC. 2870 SCHERER DR., SUITE 300 St. Petersburg,  FL  33716
ContactLuis Ruiz
CorrespondentLuis Ruiz
LENSTEC, INC. 2870 SCHERER DR., SUITE 300 St. Petersburg,  FL  33716
Product CodeMSS  
CFR Regulation Number886.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-03-11
Decision Date2005-05-31
Summary:summary

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