PEN-INJECT 2.25— 510(k) K954729
Substantially EquivalentScandinavian Health , Ltd.
FDA 510(k) clearance K954729 for PEN-INJECT 2.25, Substantially Equivalent on 1996-01-29. Applicant: Scandinavian Health , Ltd..
Clearance details
- Applicant
- Scandinavian Health , Ltd.
- Product code
- Code KZH
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
Adverse events under product code KZH
product code KZH- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . 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.