SNUG PLUG PUNCTUM PLUG

Plug, Punctum

FCI OPHTHALMICS, INC.

The following data is part of a premarket notification filed by Fci Ophthalmics, Inc. with the FDA for Snug Plug Punctum Plug.

Pre-market Notification Details

Device IDK061398
510k NumberK061398
Device Name:SNUG PLUG PUNCTUM PLUG
ClassificationPlug, Punctum
Applicant FCI OPHTHALMICS, INC. 344 ANNABELLE POINT RD. Centerville,  MA  02632 -2402
ContactHillard W Welch
CorrespondentHillard W Welch
FCI OPHTHALMICS, INC. 344 ANNABELLE POINT RD. Centerville,  MA  02632 -2402
Product CodeLZU  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-05-19
Decision Date2006-07-11

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