COLLAGEN INTRACANALICULAR PLUG

Plug, Punctum

OASIS MEDICAL, INC.

The following data is part of a premarket notification filed by Oasis Medical, Inc. with the FDA for Collagen Intracanalicular Plug.

Pre-market Notification Details

Device IDK946357
510k NumberK946357
Device Name:COLLAGEN INTRACANALICULAR PLUG
ClassificationPlug, Punctum
Applicant OASIS MEDICAL, INC. 514 SOUTH VERMONT AVE. P.O. BOX 1137 Glendora,  CA  91741
ContactJames Christensen
CorrespondentJames Christensen
OASIS MEDICAL, INC. 514 SOUTH VERMONT AVE. P.O. BOX 1137 Glendora,  CA  91741
Product CodeLZU  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-12-30
Decision Date1995-02-07

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