510(k) K202732
K202732 is an FDA 510(k) premarket notification submitted by Sol-Millennium Medical Group for the device "SOL-CARE IV Bag Safety Connector". The FDA issued a decision of Substantially Equivalent on Nov 3, 2021. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 3, 2021
- Date Received
- Sep 18, 2020
- 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
- 510(k)