AMERSE— 510(k) K931477

Substantially Equivalent

Calgon Vestal Div.

FDA 510(k) clearance K931477 for AMERSE, Substantially Equivalent on 1994-06-17. Applicant: Calgon Vestal Div..

Clearance details

Applicant: Calgon Vestal Div.
Product code: Code LRJ
Advisory panel: General Hospital
Date received: 1993-03-24
Decision date: 1994-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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Adverse events under product code LRJ

product code LRJ

Injury: 958
Total: 958

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.