Boston Keratoprosthesis, Type I Lucia

Keratoprosthesis, Permanent Implant

Massachusetts Eye And Ear Infirmary D/b/a Boston

The following data is part of a premarket notification filed by Massachusetts Eye And Ear Infirmary D/b/a Boston with the FDA for Boston Keratoprosthesis, Type I Lucia.

Pre-market Notification Details

Device IDK182986
510k NumberK182986
Device Name:Boston Keratoprosthesis, Type I Lucia
ClassificationKeratoprosthesis, Permanent Implant
Applicant Massachusetts Eye And Ear Infirmary D/b/a Boston Keratoprosthesis 243 Charles Street Boston,  MA  02114
ContactJames Chodosh
CorrespondentKristy Katzenmeyer-pleuss
Namsa Industrie Center Obernburg Obernburg Am Main,  DE 63784
Product CodeHQM  
CFR Regulation Number886.3400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-29
Decision Date2019-01-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00862395000214 K182986 000

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