510(k) K233132
K233132 is an FDA 510(k) premarket notification submitted by Primus Sterilizer Company, LLC for the device "PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)". The FDA issued a decision of Substantially Equivalent on December 19, 2023. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Primus Sterilizer Company, LLC has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2023
- Date Received
- September 27, 2023
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilizer, Steam
- Device Class
- Class II
- Regulation Number
- 880.6880
- Review Panel
- HO
- Submission Type