AEROSOL MASKS, 81426, 81476, 81490 & 81492— 510(k) K913220

Substantially Equivalent

Specialty Packaging Producs, Inc.

FDA 510(k) clearance K913220 for AEROSOL MASKS, 81426, 81476, 81490 & 81492, Substantially Equivalent on 1991-10-10. Applicant: Specialty Packaging Producs, Inc..

Clearance details

Applicant: Specialty Packaging Producs, Inc.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 1991-07-19
Decision date: 1991-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Paso, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

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.