510(k) K222905
K222905 is an FDA 510(k) premarket notification submitted by Ningbo Maxcon Medical Technology Co., Ltd. for the device "Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324)". The FDA issued a decision of Substantially Equivalent on June 1, 2023. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570. Ningbo Maxcon Medical Technology Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 1, 2023
- Date Received
- September 23, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Container, Sharps
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type