510(k) K181396
K181396 is an FDA 510(k) premarket notification submitted by Passion For Life Healthcare (Uk) Limited for the device "Oral Device OA, Oral Device S". The FDA issued a decision of Substantially Equivalent on Nov 16, 2018. The device falls under product code LRK (Device, Anti-Snoring), a Class II device regulated under 21 CFR 872.5570.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 16, 2018
- Date Received
- May 29, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Anti-Snoring
- Device Class
- Class II
- Regulation Number
- 872.5570
- Review Panel
- DE
- Submission Type
- 510(k)