SILASTIC VOICE PROSTHESIS— 510(k) K812864
Substantially EquivalentDow Corning Corp. Healthcare Industries Materials
FDA 510(k) clearance K812864 for SILASTIC VOICE PROSTHESIS, Substantially Equivalent on 1981-11-24. Applicant: Dow Corning Corp. Healthcare Industries Materials.
Clearance details
- Applicant
- Dow Corning Corp. Healthcare Industries Materials
- Product code
- Code EWL
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code EWL
product code EWL- Death
- 2
- Total
- 2
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.