SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001— 510(k) K071180
Substantially EquivalentEngineered Medical Solutions Co., LLC
FDA 510(k) clearance K071180 for SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001, Substantially Equivalent on 2007-06-20. Applicant: Engineered Medical Solutions Co., LLC.
Clearance details
- Applicant
- Engineered Medical Solutions Co., LLC
- Product code
- Code FTD
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Leola, PA, US
Adverse events under product code FTD
product code FTD- Malfunction
- 767
- Total
- 767
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.