510(k) K222093
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 2022
- Date Received
- July 15, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilizer, Chemical
- Device Class
- Class II
- Regulation Number
- 880.6860
- Review Panel
- HO
- Submission Type