510(k) K211419
K211419 is an FDA 510(k) premarket notification submitted by Belport Company, Inc., Gingi-Pak for the device "Gingi-Aid Gel". The FDA issued a decision of Substantially Equivalent on January 10, 2022. The device falls under product code MVL (Cord, Retraction), a Class U device. Belport Company, Inc., Gingi-Pak has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 10, 2022
- Date Received
- May 7, 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