510(k) K152857
K152857 is an FDA 510(k) premarket notification submitted by Neomed, Inc. for the device "NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps". The FDA issued a decision of Substantially Equivalent on December 17, 2015. The device falls under product code PNR (Enteral Syringes With Enteral Specific Connectors), a Class II device regulated under 21 CFR 876.5980. Neomed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 2015
- Date Received
- September 30, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enteral Syringes With Enteral Specific Connectors
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type
Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors.