COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG,

Plug, Punctum

PARAGON BIOTECK, INC.

The following data is part of a premarket notification filed by Paragon Bioteck, Inc. with the FDA for Comfortear Lacrisolve Absorbable Punctum Plug, Lacrisolve Absorbable Punctum Plug, Comfortear Lacrisolve Punctum Plug,.

Pre-market Notification Details

Device IDK140711
510k NumberK140711
Device Name:COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG,
ClassificationPlug, Punctum
Applicant PARAGON BIOTECK, INC. 4640 SW MACADAM, STE 80 Portland,  OR  97239
ContactLauren M-c Bluett
CorrespondentLauren M-c Bluett
PARAGON BIOTECK, INC. 4640 SW MACADAM, STE 80 Portland,  OR  97239
Product CodeLZU  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-21
Decision Date2014-06-20
Summary:summary

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