CONE MASKS, VARIOUS TYPES OF SURGICAL CONE MASKS— 510(k) K883828

Substantially Equivalent

Greene International Corp.

FDA 510(k) clearance K883828 for CONE MASKS, VARIOUS TYPES OF SURGICAL CONE MASKS, Substantially Equivalent on 1988-10-03. Applicant: Greene International Corp..

Clearance details

Applicant: Greene International Corp.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1988-09-09
Decision date: 1988-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: (Formosa) R.O.C., TW

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Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

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.