510(k) K193389
K193389 is an FDA 510(k) premarket notification submitted by Inter-Med/Vista Dental Products for the device "Vista Clear". The FDA issued a decision of Substantially Equivalent on March 4, 2020. The device falls under product code MVL (Cord, Retraction), a Class U device. Inter-Med/Vista Dental Products has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 4, 2020
- Date Received
- December 6, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cord, Retraction
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type