510(k) K160101
K160101 is an FDA 510(k) premarket notification submitted by Bioinspire Technologies, Incorporated for the device "SinuBand". The FDA issued a decision of Substantially Equivalent on July 27, 2016. The device falls under product code QJL (Splint, Intranasal Septal, Cber Led), a Class I device regulated under 21 CFR 874.4780.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 2016
- Date Received
- January 19, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Splint, Intranasal Septal, Cber Led
- Device Class
- Class I
- Regulation Number
- 874.4780
- Review Panel
- EN
- Submission Type
Splint, Intranasal Septal, CBER led