510(k) K201091
K201091 is an FDA 510(k) premarket notification submitted by Voco GmbH for the device "V-Print splint". The FDA issued a decision of Substantially Equivalent on November 6, 2020. The device falls under product code MQC (Mouthguard, Prescription), a Class U device. Voco GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 6, 2020
- Date Received
- April 23, 2020
- 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