COMBO 36— 510(k) K854257

Name: FDA 510(k) clearance K854257
Creator: U.S. Food and Drug Administration
Published: 1985-11-18

Substantially Equivalent

Kg Engineering, Inc.

FDA 510(k) clearance K854257 for COMBO 36, Substantially Equivalent on 1985-11-18. Applicant: Kg Engineering, Inc.. Device class: 1.

Clearance details

Applicant: Kg Engineering, Inc.
Product code: Code FNJ
Device class: Class 1
Regulation: 21 CFR 880.5120
Advisory panel: General Hospital
Date received: 1985-10-22
Decision date: 1985-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woonsocket, RI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FNJ

product code FNJ

Death: 6
Total: 6

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.