The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Fresenius Priming Set With Needles Access Port, Model 04-9002-9.
| Device ID | K010268 |
| 510k Number | K010268 |
| Device Name: | FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9 |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| 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 | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-29 |
| Decision Date | 2001-04-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840861100511 | K010268 | 000 |