CONFIDOSE IM AUTO-INJECTOR— 510(k) K060389

Substantially Equivalent

Pharma-Pen, Inc.

FDA 510(k) clearance K060389 for CONFIDOSE IM AUTO-INJECTOR, Substantially Equivalent on 2006-06-06. Applicant: Pharma-Pen, Inc..

Clearance details

Applicant: Pharma-Pen, Inc.
Product code: Code KZH
Advisory panel: General Hospital
Date received: 2006-02-14
Decision date: 2006-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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Adverse events under product code KZH

product code KZH

Other: 1
Total: 1

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.