PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70— 510(k) K092012

Substantially Equivalent

Primed Medical Products, Inc.

FDA 510(k) clearance K092012 for PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70, Substantially Equivalent on 2009-09-25. Applicant: Primed Medical Products, Inc..

Clearance details

Applicant: Primed Medical Products, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2009-07-06
Decision date: 2009-09-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Edmonton, Alberta, CA

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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.