510(k) K182052
K182052 is an FDA 510(k) premarket notification submitted by Hologic, Inc. for the device "Omni Instrument Tray". The FDA issued a decision of Substantially Equivalent on Feb 26, 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. Hologic, Inc. has 119 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 26, 2019
- Date Received
- Jul 31, 2018
- 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)