The following data is part of a premarket notification filed by Neomed, Inc. with the FDA for Neomed Single Lumen Umbilical Catheter.
| Device ID | K073596 |
| 510k Number | K073596 |
| Device Name: | NEOMED SINGLE LUMEN UMBILICAL CATHETER |
| Classification | Catheter, Umbilical Artery |
| Applicant | NEOMED, INC. 717 LAKEGLEN DR. Suwanee, GA 30024 |
| Contact | Penny Northcutt |
| Correspondent | Penny Northcutt NEOMED, INC. 717 LAKEGLEN DR. Suwanee, GA 30024 |
| Product Code | FOS |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-21 |
| Decision Date | 2008-02-22 |
| Summary: | summary |