510(k) K260845
K260845 is an FDA 510(k) premarket notification submitted by Tianjin Huahong Technology Co., Ltd. for the device "Huahong Sharps Container (HHR-I, HHR-II)". The FDA issued a decision of Substantially Equivalent on Aug 5, 2026. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570. Tianjin Huahong Technology Co., Ltd. has 15 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 5, 2026
- Date Received
- Mar 16, 2026
- 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
- 510(k)