BYRD STAINLESS STEEL DILATOR— 510(k) K902502
Substantially EquivalentMedical Engineering and Development Institute
FDA 510(k) clearance K902502 for BYRD STAINLESS STEEL DILATOR, Substantially Equivalent on 1990-08-07. Applicant: Medical Engineering and Development Institute.
Clearance details
- Applicant
- Medical Engineering and Development Institute
- Product code
- Code GCC
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Lafayette, IN, US
Adverse events under product code GCC
product code GCC- Death
- 3
- Total
- 3
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.