LacriPro Punctum Plug

Plug, Punctum

LACRIMEDICS, INC.

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

Pre-market Notification Details

Device IDK161673
510k NumberK161673
Device Name:LacriPro Punctum Plug
ClassificationPlug, Punctum
Applicant LACRIMEDICS, INC. 2620 WILLIAMSON PLACE NW, SUITE 113 Dupont,  WA  98245
ContactRebecca C. Dutton
CorrespondentRebecca C. Dutton
LACRIMEDICS, INC. 2620 WILLIAMSON PLACE NW, SUITE 113 Dupont,  WA  98245
Product CodeLZU  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-06-16
Decision Date2016-11-18
Summary:summary

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