BOSTON KERATOPROSTHESIS OR BOSTON KPRO

Keratoprosthesis, Permanent Implant

MASSACHUSETTS EYE & EAR INFIRMARY

The following data is part of a premarket notification filed by Massachusetts Eye & Ear Infirmary with the FDA for Boston Keratoprosthesis Or Boston Kpro.

Pre-market Notification Details

Device IDK121203
510k NumberK121203
Device Name:BOSTON KERATOPROSTHESIS OR BOSTON KPRO
ClassificationKeratoprosthesis, Permanent Implant
Applicant MASSACHUSETTS EYE & EAR INFIRMARY 49 PLAIN STREET North Attleboro,  MA  02760
ContactBrian J Edwards
CorrespondentBrian J Edwards
MASSACHUSETTS EYE & EAR INFIRMARY 49 PLAIN STREET North Attleboro,  MA  02760
Product CodeHQM  
CFR Regulation Number886.3400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-04-20
Decision Date2013-05-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00862395000207 K121203 000
00862394000291 K121203 000
00862394000284 K121203 000
00862394000277 K121203 000
00862394000253 K121203 000
00862394000246 K121203 000

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