PleuraFlow System— 510(k) K153681
Substantially EquivalentClearflow, Inc.
FDA 510(k) clearance K153681 for PleuraFlow System, Substantially Equivalent on 2016-01-20. Applicant: Clearflow, Inc.. Device class: 2.
Clearance details
- Applicant
- Clearflow, Inc.
- Product code
- Code OTK
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Anaheim, CA, US
Recent devices under product code OTK
view allData sourced from openFDA. This site is unofficial and independent of the FDA.