OPHTA SIL- PUNCTAL PLUGS (MODIFICATION)— 510(k) K954094

Name: FDA 510(k) clearance K954094
Creator: U.S. Food and Drug Administration
Published: 1995-10-05

Substantially Equivalent

G.W.B. Intl., Ltd.

FDA 510(k) clearance K954094 for OPHTA SIL- PUNCTAL PLUGS (MODIFICATION), Substantially Equivalent on 1995-10-05. Applicant: G.W.B. Intl., Ltd.. Device class: Unclassified.

Clearance details

Applicant: G.W.B. Intl., Ltd.
Product code: Code LZU
Device class: Unclassified
Advisory panel: Unknown
Date received: 1995-08-24
Decision date: 1995-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marshfield, MA, 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.