510(k) K153270
K153270 is an FDA 510(k) premarket notification submitted by Bionix Development Corp. for the device "TruGuard Custom Tongue and Jaw Positioner". The FDA issued a decision of Substantially Equivalent on March 8, 2016. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Bionix Development Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 2016
- Date Received
- November 12, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accelerator, Linear, Medical
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type