510(k) K170985
K170985 is an FDA 510(k) premarket notification submitted by Tmj Services, LLC for the device "Urbanek Device". The FDA issued a decision of Substantially Equivalent on Sep 25, 2017. The device falls under product code MQC (Mouthguard, Prescription), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 25, 2017
- Date Received
- Apr 3, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mouthguard, Prescription
- Device Class
- Class U
- Review Panel
- DE
- Submission Type
- 510(k)