510(k) K222508
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 1, 2022
- Date Received
- August 18, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Indicator, Physical/Chemical Sterilization Process
- Device Class
- Class II
- Regulation Number
- 880.2800
- Review Panel
- HO
- Submission Type