510(k) K191566
K191566 is an FDA 510(k) premarket notification submitted by Avinent Implant System S.L.U. for the device "Avinent Surgical Tray". The FDA issued a decision of Substantially Equivalent on March 6, 2020. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Avinent Implant System S.L.U. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 6, 2020
- Date Received
- June 13, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Device Class
- Class II
- Regulation Number
- 880.6850
- Review Panel
- HO
- Submission Type