The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Fresenius Staysafe Patient Connectors, Model 050-87211.
| Device ID | K041792 |
| 510k Number | K041792 |
| Device Name: | FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211 |
| Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
| 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 | KDJ |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-02 |
| Decision Date | 2004-09-24 |
| Summary: | summary |