NovaGuard SA Pro Safety System— 510(k) K163511
Substantially EquivalentWest Pharmaceutical Services, Inc.
FDA 510(k) clearance K163511 for NovaGuard SA Pro Safety System, Substantially Equivalent on 2017-02-02. Applicant: West Pharmaceutical Services, Inc..
Clearance details
- Applicant
- West Pharmaceutical Services, Inc.
- Product code
- Code MEG
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Exton, PA, US
Adverse events under product code MEG
product code MEG- Malfunction
- 1,373
- Other
- 1
- Total
- 1,374
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.