MASKS, VARIOUS TYPES OF SURGICAL MASKS— 510(k) K883827

Substantially Equivalent

Greene International Corp.

FDA 510(k) clearance K883827 for MASKS, VARIOUS TYPES OF SURGICAL MASKS, Substantially Equivalent on 1988-11-17. 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: 1988-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: (Formosa) R.O.C., TW

Download summary PDF View on FDA.gov ↗

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.