DOHLMAN DOANE KERATOPROTHESIS

Keratoprosthesis, Permanent Implant

MACKEEN CONSULTANTS, LTD.

The following data is part of a premarket notification filed by Mackeen Consultants, Ltd. with the FDA for Dohlman Doane Keratoprothesis.

Pre-market Notification Details

Device IDK915062
510k NumberK915062
Device Name:DOHLMAN DOANE KERATOPROTHESIS
ClassificationKeratoprosthesis, Permanent Implant
Applicant MACKEEN CONSULTANTS, LTD. 4903 SANGAMORE RD. Bethesda,  MD  20816
ContactDonald L.mackeen
CorrespondentDonald L.mackeen
MACKEEN CONSULTANTS, LTD. 4903 SANGAMORE RD. Bethesda,  MD  20816
Product CodeHQM  
CFR Regulation Number886.3400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-11-08
Decision Date1992-01-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00862394000260 K915062 000
00862394000239 K915062 000
00862394000222 K915062 000
00862394000215 K915062 000
00862394000208 K915062 000

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