TECNOL FLUIDSHIELD INFECTION CONTROL MASK— 510(k) K915817

Substantially Equivalent

Tecnol Medical Products, Inc.

FDA 510(k) clearance K915817 for TECNOL FLUIDSHIELD INFECTION CONTROL MASK, Substantially Equivalent on 1993-01-27. Applicant: Tecnol Medical Products, Inc..

Clearance details

Applicant: Tecnol Medical Products, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1991-12-30
Decision date: 1993-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

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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.