The following data is part of a premarket notification filed by Neomed, Inc. with the FDA for Neomed Neoconnect Enteral Syringes With Enfit Connector And Compatible Neosecure Tip Caps.
| Device ID | K152857 |
| 510k Number | K152857 |
| Device Name: | NeoMed NeoConnect Enteral Syringes With ENFit Connector And Compatible NeoSecure Tip Caps |
| 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 Court 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 | 2015-09-30 |
| Decision Date | 2015-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10350770003112 | K152857 | 000 |
| 00350770003108 | K152857 | 000 |
| 10350770000388 | K152857 | 000 |
| 20350770000378 | K152857 | 000 |