510(k) K190310
K190310 is an FDA 510(k) premarket notification submitted by U Deliver Medical, LLC for the device "U Deliver Bolink ENFit Enteral Feeding Sets". The FDA issued a decision of Substantially Equivalent on May 31, 2019. The device falls under product code PIF (Gastrointestinal Tubes With Enteral Specific Connectors), a Class II device regulated under 21 CFR 876.5980. U Deliver Medical, LLC has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 31, 2019
- Date Received
- Feb 12, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gastrointestinal Tubes With Enteral Specific Connectors
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type
- 510(k)
To facilitate enteral specific connections.