SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT— 510(k) K133425
Substantially EquivalentEngineered Medical Solutions Co., LLC
FDA 510(k) clearance K133425 for SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT, Substantially Equivalent on 2013-12-05. Applicant: Engineered Medical Solutions Co., LLC. Device class: 2.
Clearance details
- Applicant
- Engineered Medical Solutions Co., LLC
- Product code
- Code FTD
- Device class
- Class 2
- Regulation
- 21 CFR 878.4580
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Phillipsburg, NJ, US
Recent devices under product code FTD
view allMore clearances from Engineered Medical Solutions Co., LLC
view allAdverse 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.