510(k) K183090
- Device
- Relieva Tract Balloon Dilation System
- Applicant
- Acclarent, Inc.
- 510(k) number
- K183090
- Product code
- QGK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-04-19
- Date received
- 2018-11-06
- Regulation
- 874.4420
- Classification name
- Balloon, Nasal Airway
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Leena Sorathia
- Address
- 33 Technology Dr. Irvin CA US 92618 92618
FDA Registration Numbers#
- 3005172759
- 3003678543
- 3008087383
- 3003418325
- 3010273872