XprESS ENT Dilation System— 510(k) K163509
Substantially EquivalentEntellus Medical, Inc.
FDA 510(k) clearance K163509 for XprESS ENT Dilation System, Substantially Equivalent on 2017-04-05. Applicant: Entellus Medical, Inc..
Clearance details
- Applicant
- Entellus Medical, Inc.
- Product code
- Code PNZ
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.