The following data is part of a premarket notification filed by Neomed, Inc. with the FDA for Neomed Neoconnect Enteral Syringes With Enfit Connector.
| Device ID | K143344 |
| 510k Number | K143344 |
| Device Name: | NeoMed NeoConnect Enteral Syringes With ENFit Connector |
| Classification | Enteral Syringes With Enteral Specific Connectors |
| Applicant | NEOMED, INC. 100 Londonderry Ct Suite 112 Woodstock, GA 30188 |
| Contact | Tony Lair |
| Correspondent | Melinda Harrison Smith NEOMED, INC. 100 Londonderry Ct Suite 112 Woodstock, GA 30188 |
| Product Code | PNR |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-21 |
| Decision Date | 2015-04-09 |
| Summary: | summary |