SinuBand— 510(k) K160101
Substantially EquivalentBioinspire Technologies, Incorporated
FDA 510(k) clearance K160101 for SinuBand, Substantially Equivalent on 2016-07-27. Applicant: Bioinspire Technologies, Incorporated. Device class: 1.
Clearance details
- Applicant
- Bioinspire Technologies, Incorporated
- Product code
- Code QJL
- Device class
- Class 1
- Regulation
- 21 CFR 874.4780
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palo Alto, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.