C-MASK(FLAT)— 510(k) K882883

Substantially Equivalent

Promedica Products, Inc.

FDA 510(k) clearance K882883 for C-MASK(FLAT), Substantially Equivalent on 1988-08-10. Applicant: Promedica Products, Inc..

Clearance details

Applicant: Promedica Products, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1988-07-11
Decision date: 1988-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newport Beach, CA, 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.