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.. Device class: 2.
Clearance details
- Applicant
- Entellus Medical, Inc.
- Product code
- Code PNZ
- Device class
- Class 2
- Regulation
- 21 CFR 874.4180
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
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