The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Fresenius Capd Stay.safe Disposable Administration Sets With Stay.safe Connector.
| Device ID | K022412 |
| 510k Number | K022412 |
| Device Name: | FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR |
| Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
| Applicant | FRESENIUS MEDICAL CARE NORTH AMERICA 95 HAYDEN AVE. Lexington, MA 02420 -9192 |
| Contact | Arthur E Eilinsfeld |
| Correspondent | Arthur E 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 | 2002-07-24 |
| Decision Date | 2003-03-05 |
| Summary: | summary |