PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS— 510(k) K081633

Substantially Equivalent

Primed Medical Products, Inc.

FDA 510(k) clearance K081633 for PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS, Substantially Equivalent on 2008-08-11. Applicant: Primed Medical Products, Inc..

Clearance details

Applicant: Primed Medical Products, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2008-06-11
Decision date: 2008-08-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Edmonton, Alberta, CA

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.