The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Fresenius Arterial Bloodline Sets For Hemodialysis, Fresenius Combi Sets Hemodialysis Blood Tubing Sets.
| Device ID | K012242 |
| 510k Number | K012242 |
| Device Name: | FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| 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 | FJK |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-17 |
| Decision Date | 2001-08-16 |
| Summary: | summary |