OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS— 510(k) K911108

Substantially Equivalent

G.W.B. Intl., Ltd.

FDA 510(k) clearance K911108 for OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS, Substantially Equivalent on 1991-05-13. Applicant: G.W.B. Intl., Ltd..

Clearance details

Applicant: G.W.B. Intl., Ltd.
Product code: Code LZU
Advisory panel: Unknown
Date received: 1991-03-04
Decision date: 1991-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sudbury, MA, 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.