510(k) K182819
K182819 is an FDA 510(k) premarket notification submitted by Gcmedica Enterprise Ltd.(Wuxi) for the device "Decanting Device". The FDA issued a decision of Substantially Equivalent on December 2, 2019. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Gcmedica Enterprise Ltd.(Wuxi) has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 2019
- Date Received
- October 4, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, I.V. Fluid Transfer
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type