VALUMAX SURGICAL MASKS (BLUE, PINK, GREEN, YELLOW, WHITE AND PEACH) WITH OR WITHOUT VISORS, TIES AND EARLOOPS— 510(k) K040333

Substantially Equivalent

Valumax Intl., Inc.

FDA 510(k) clearance K040333 for VALUMAX SURGICAL MASKS (BLUE, PINK, GREEN, YELLOW, WHITE AND PEACH) WITH OR WITHOUT VISORS, TIES AND EARLOOPS, Substantially Equivalent on 2004-06-07. Applicant: Valumax Intl., Inc..

Clearance details

Applicant: Valumax Intl., Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2004-02-11
Decision date: 2004-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allentown, PA, US

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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.