510(k) K192487
K192487 is an FDA 510(k) premarket notification submitted by K1 Medical, LLC for the device "EZ-TRAX Containment Device". The FDA issued a decision of Substantially Equivalent on Dec 23, 2019. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. K1 Medical, LLC has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 23, 2019
- Date Received
- Sep 11, 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
- 510(k)