510(k) K201523
K201523 is an FDA 510(k) premarket notification submitted by Zhejiang Gongdong Medical Technology Co., Ltd. for the device "Sharps container". The FDA issued a decision of Substantially Equivalent on November 12, 2020. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570. Zhejiang Gongdong Medical Technology Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 2020
- Date Received
- June 8, 2020
- 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