LumenR Tissue Retractor System— 510(k) K153698
Substantially EquivalentLumenr, LLC
FDA 510(k) clearance K153698 for LumenR Tissue Retractor System, Substantially Equivalent on 2016-04-19. Applicant: Lumenr, LLC. Device class: 2.
Clearance details
- Applicant
- Lumenr, LLC
- Product code
- Code ODB
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Matawan, NJ, US
Recent devices under product code ODB
view allData sourced from openFDA. This site is unofficial and independent of the FDA.