PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306— 510(k) K001951

Substantially Equivalent

Primeline Medical Products, Inc.

FDA 510(k) clearance K001951 for PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306, Substantially Equivalent on 2000-09-08. Applicant: Primeline Medical Products, Inc..

Clearance details

Applicant: Primeline Medical Products, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2000-06-27
Decision date: 2000-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
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.