510(k) K213149
K213149 is an FDA 510(k) premarket notification submitted by Voco GmbH for the device "VOCO Retraction Paste". The FDA issued a decision of Substantially Equivalent on December 9, 2021. The device falls under product code MVL (Cord, Retraction), a Class U device. Voco GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 2021
- Date Received
- September 27, 2021
- 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