ALLEN UNIVERSAL STIRRUP— 510(k) K860177
Substantially EquivalentEdgewater Medical Equipment Systems
FDA 510(k) clearance K860177 for ALLEN UNIVERSAL STIRRUP, Substantially Equivalent on 1986-02-11. Applicant: Edgewater Medical Equipment Systems.
Clearance details
- Applicant
- Edgewater Medical Equipment Systems
- Product code
- Code BWN
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mayfield Hts., OH, US
Adverse events under product code BWN
product code BWN- Other
- 1
- Total
- 1
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.