FDA 510(k) Applications for Medical Device:
Hemodialyzer, Re-Use, Low Flux
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K983720 | ASAHI MEDICAL CO., LTD. |
15825 SHADY GROVE ROAD, | ROCKVILLE | MD | 20850 |
| K970650 | ASAHI MEDICAL CO., LTD. |
15825 SHADY GROVE ROAD, | ROCKVILLE | MD | 20850 |
| K970661 | BAXTER HEALTHCARE CORP. |
1620 WAULKEGAN RD. | MCGAW PARK | IL | 60085-6730 |
| K970654 | BAXTER HEALTHCARE CORP. |
1620 WAULKEGAN RD. | MCGAW PARK | IL | 60085-6730 |
| K001685 | BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN RD., MPR-A2E | MCGAW PARK | IL | 60085-6730 |
| K974090 | FRESENIUS MEDICAL CARE NORTH AMERICA |
2637 SHADELANDS DR. | WALNUT CREEK | CA | 94598 |
| K970700 | FRESENIUS USA, INC. |
2637 SHADELANDS DR. | WALNUT CREEK | CA | 94598 |
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