COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG,— 510(k) K140711

Name: FDA 510(k) clearance K140711
Creator: U.S. Food and Drug Administration
Published: 2014-06-20

Substantially Equivalent

Paragon Bioteck, Inc.

FDA 510(k) clearance K140711 for COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG,, Substantially Equivalent on 2014-06-20. Applicant: Paragon Bioteck, Inc.. Device class: Unclassified.

Clearance details

Applicant: Paragon Bioteck, Inc.
Product code: Code LZU
Device class: Unclassified
Advisory panel: Unknown
Date received: 2014-03-21
Decision date: 2014-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LZU

product code LZU

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.