510(k) K162816
K162816 is an FDA 510(k) premarket notification submitted by Selane Products, Inc. for the device "SML-OSA2 Appliances". The FDA issued a decision of Substantially Equivalent on July 27, 2017. The device falls under product code LQZ (Device, Jaw Repositioning), a Class II device regulated under 21 CFR 872.5570. Selane Products, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 2017
- Date Received
- October 6, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Jaw Repositioning
- Device Class
- Class II
- Regulation Number
- 872.5570
- Review Panel
- DE
- Submission Type