510(k) K223015
K223015 is an FDA 510(k) premarket notification submitted by Plasmapp Co,., Ltd. for the device "STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette". The FDA issued a decision of Substantially Equivalent on May 9, 2023. The device falls under product code MLR (Sterilizer, Chemical), a Class II device regulated under 21 CFR 880.6860. Plasmapp Co,., Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 2023
- Date Received
- September 29, 2022
- Clearance Type
- Traditional
- 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