MODIFICATION TO: MINIMESH POLYPROPYLENE MESH— 510(k) K053361
Substantially EquivalentMpathy Medical Devices, Ltd.
FDA 510(k) clearance K053361 for MODIFICATION TO: MINIMESH POLYPROPYLENE MESH, Substantially Equivalent on 2006-02-06. Applicant: Mpathy Medical Devices, Ltd..
Clearance details
- Applicant
- Mpathy Medical Devices, Ltd.
- Product code
- Code OTO
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Farfield, CT, US
Adverse events under product code OTO
product code OTO- Injury
- 840
- Total
- 840
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.