510(k) K222608
K222608 is an FDA 510(k) premarket notification submitted by Tuttnauer , Ltd. for the device "Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS". The FDA issued a decision of Substantially Equivalent on December 16, 2022. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Tuttnauer , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 2022
- Date Received
- August 29, 2022
- Clearance Type
- Traditional
- 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