510(k) K162536
K162536 is an FDA 510(k) premarket notification submitted by Kerr Corporation for the device "GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord". The FDA issued a decision of Substantially Equivalent on February 3, 2017. The device falls under product code MVL (Cord, Retraction), a Class U device. Kerr Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 3, 2017
- Date Received
- September 12, 2016
- 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