NOVAGUARD, MODEL 3611001— 510(k) K082908
Substantially EquivalentWest Pharmaceutical Services, Inc.
FDA 510(k) clearance K082908 for NOVAGUARD, MODEL 3611001, Substantially Equivalent on 2009-04-24. Applicant: West Pharmaceutical Services, Inc.. Device class: 2.
Clearance details
- Applicant
- West Pharmaceutical Services, Inc.
- Product code
- Code FMI
- Device class
- Class 2
- Regulation
- 21 CFR 880.5570
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Lionville, PA, US
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More clearances from West Pharmaceutical Services, Inc.
view allAdverse events under product code FMI
product code FMI- Death
- 28
- Injury
- 1,517
- Malfunction
- 23,981
- Other
- 18
- Total
- 25,544
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.