510(k) K223365
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2023
- Date Received
- November 3, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coating, Filling Material, Resin
- Device Class
- Class II
- Regulation Number
- 872.3310
- Review Panel
- DE
- Submission Type