PROCEDURE MASKS: PM4-301 AND PM4-304— 510(k) K011789

Substantially Equivalent

Primeline Medical Products, Inc.

FDA 510(k) clearance K011789 for PROCEDURE MASKS: PM4-301 AND PM4-304, Substantially Equivalent on 2001-06-22. Applicant: Primeline Medical Products, Inc..

Clearance details

Applicant: Primeline Medical Products, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2001-06-08
Decision date: 2001-06-22
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.