The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Split Septum Injection Sites.
| Device ID | K041042 |
| 510k Number | K041042 |
| Device Name: | SPLIT SEPTUM INJECTION SITES |
| Classification | Set, Administration, Intravascular |
| Applicant | FRESENIUS MEDICAL CARE NORTH AMERICA 95 HAYDEN AVE. Lexington, MA 02420 -9192 |
| Contact | Arthur Eilinsfeld |
| Correspondent | Arthur Eilinsfeld FRESENIUS MEDICAL CARE NORTH AMERICA 95 HAYDEN AVE. Lexington, MA 02420 -9192 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-22 |
| Decision Date | 2004-07-16 |
| Summary: | summary |