DISP. SURGICAL FACE MASK— 510(k) K771409

Substantially Equivalent

Precept, Inc.

FDA 510(k) clearance K771409 for DISP. SURGICAL FACE MASK, Substantially Equivalent on 1977-10-27. Applicant: Precept, Inc..

Clearance details

Applicant: Precept, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1977-08-01
Decision date: 1977-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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.