SPA SHELL— 510(k) K904106

Name: FDA 510(k) clearance K904106
Creator: U.S. Food and Drug Administration
Published: 1990-09-18

Substantially Equivalent

Century Manufacturing Co.

FDA 510(k) clearance K904106 for SPA SHELL, Substantially Equivalent on 1990-09-18. Applicant: Century Manufacturing Co.. Device class: 2.

Clearance details

Applicant: Century Manufacturing Co.
Product code: Code ILJ
Device class: Class 2
Regulation: 21 CFR 890.5100
Advisory panel: Physical Medicine
Date received: 1990-09-06
Decision date: 1990-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aurora, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ILJ

product code ILJ

Death: 4
Total: 4

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.