VENTURI NEGATIVE PRESSURE WOUND THERAPY SYSTEM— 510(k) K080897
Substantially EquivalentTalley Medical
FDA 510(k) clearance K080897 for VENTURI NEGATIVE PRESSURE WOUND THERAPY SYSTEM, Substantially Equivalent on 2008-07-15. Applicant: Talley Medical. Device class: 2.
Clearance details
- Applicant
- Talley Medical
- Product code
- Code OMP
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Williamston, MI, US
Recent devices under product code OMP
view allMore clearances from Talley Medical
view allAdverse events under product code OMP
product code OMP- Death
- 31
- Injury
- 1,707
- Malfunction
- 4,047
- Other
- 1
- Total
- 5,786
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.