FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK— 510(k) K911891

Substantially Equivalent

Tecnol New Jersey Wound Care, Inc.

FDA 510(k) clearance K911891 for FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK, Substantially Equivalent on 1991-07-12. Applicant: Tecnol New Jersey Wound Care, Inc..

Clearance details

Applicant: Tecnol New Jersey Wound Care, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1991-04-29
Decision date: 1991-07-12
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.