510(k) K190107
K190107 is an FDA 510(k) premarket notification submitted by Whip Mix Corporation for the device "VeriSplint". The FDA issued a decision of Substantially Equivalent on July 10, 2019. The device falls under product code MQC (Mouthguard, Prescription), a Class U device. Whip Mix Corporation has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 2019
- Date Received
- January 22, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mouthguard, Prescription
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type