UNFOLDER Vitan Inserter

Folders And Injectors, Intraocular Lens (iol)

Johnson & Johnson Surgical Vision, Inc.

The following data is part of a premarket notification filed by Johnson & Johnson Surgical Vision, Inc. with the FDA for Unfolder Vitan Inserter.

Pre-market Notification Details

Device IDK191949
510k NumberK191949
Device Name:UNFOLDER Vitan Inserter
ClassificationFolders And Injectors, Intraocular Lens (iol)
Applicant Johnson & Johnson Surgical Vision, Inc. 1700 East Saint Andrew Place Santa Ana,  CA  92705
ContactSilvia Jiang-hughes
CorrespondentSilvia Jiang-hughes
Johnson & Johnson Surgical Vision, Inc. 1700 East Saint Andrew Place Santa Ana,  CA  92705
Product CodeMSS  
CFR Regulation Number886.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-22
Decision Date2019-09-13
Summary:summary

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