KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER— 510(k) K061197

Substantially Equivalent

Kawasumi Laboratories, Inc.

FDA 510(k) clearance K061197 for KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER, Substantially Equivalent on 2006-06-30. Applicant: Kawasumi Laboratories, Inc..

Clearance details

Applicant: Kawasumi Laboratories, Inc.
Product code: Code KPE
Advisory panel: General Hospital
Date received: 2006-04-28
Decision date: 2006-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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Adverse events under product code KPE

product code KPE

Malfunction: 1,000
Other: 1
Total: 1,001

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.