SHL DISPOSABLE AUTOINJECTOR— 510(k) K050434
Substantially EquivalentShl Medical, USA
FDA 510(k) clearance K050434 for SHL DISPOSABLE AUTOINJECTOR, Substantially Equivalent on 2005-06-24. Applicant: Shl Medical, USA.
Clearance details
- Applicant
- Shl Medical, USA
- Product code
- Code KZH
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Florham Park, NJ, 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.