SOFT PLUG Extended Duration 180 Tapered Canalicular Plug

Plug, Punctum

Oasis Medical, Inc

The following data is part of a premarket notification filed by Oasis Medical, Inc with the FDA for Soft Plug Extended Duration 180 Tapered Canalicular Plug.

Pre-market Notification Details

Device IDK213988
510k NumberK213988
Device Name:SOFT PLUG Extended Duration 180 Tapered Canalicular Plug
ClassificationPlug, Punctum
Applicant Oasis Medical, Inc 514 S Vermont Avenue Glendora,  CA  91741
ContactJames Christensen
CorrespondentTing-Hsuan Wu
Oasis Medical, Inc 514 S Vermont Avenue Glendora,  CA  91741
Product CodeLZU  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-20
Decision Date2022-06-03

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