TITANIUM PEG SYSTEM

Ocular Peg

FCI OPHTHALMICS, INC.

The following data is part of a premarket notification filed by Fci Ophthalmics, Inc. with the FDA for Titanium Peg System.

Pre-market Notification Details

Device IDK980822
510k NumberK980822
Device Name:TITANIUM PEG SYSTEM
ClassificationOcular Peg
Applicant FCI OPHTHALMICS, INC. P.O. BOX 465 76 PROSPECT ST. Marshfield Hills,  MA  02051
ContactAnne Bohsack
CorrespondentAnne Bohsack
FCI OPHTHALMICS, INC. P.O. BOX 465 76 PROSPECT ST. Marshfield Hills,  MA  02051
Product CodeMQU  
CFR Regulation Number886.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-03-03
Decision Date1998-07-09

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