PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS

Plug, Punctum

FCI OPHTHALMICS, INC.

The following data is part of a premarket notification filed by Fci Ophthalmics, Inc. with the FDA for Punctum Plugs & Ready-set Punctal Plugs.

Pre-market Notification Details

Device IDK964774
510k NumberK964774
Device Name:PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS
ClassificationPlug, Punctum
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 CodeLZU  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-10-22
Decision Date1996-12-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.