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

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..

Clearance details

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

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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.