Relieva Tract Balloon Dilation System— 510(k) K183090
Substantially EquivalentAcclarent, Inc.
FDA 510(k) clearance K183090 for Relieva Tract Balloon Dilation System, Substantially Equivalent on 2019-04-19. Applicant: Acclarent, Inc.. Device class: 1.
Clearance details
- Applicant
- Acclarent, Inc.
- Product code
- Code QGK
- Device class
- Class 1
- Regulation
- 21 CFR 874.4420
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvin, CA, US
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