COMBO 36— 510(k) K854257

Substantially Equivalent

Kg Engineering, Inc.

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

Clearance details

Applicant: Kg Engineering, Inc.
Product code: Code FNJ
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 ↗

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.