FDA 510(k) Applications for Medical Device:
Hemodialyzer, Re-Use, High Flux
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K970679 | ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL |
14620 N.W. 60TH AVE. | MIAMI LAKES | FL | 33014-9308 |
| K970681 | ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL |
14620 N.W. 60TH AVE. | MIAMI LAKES | FL | 33014-9308 |
| K970662 | BAXTER HEALTHCARE CORP. |
1620 WAULKEGAN RD. | MCGAW PARK | IL | 60085-6730 |
| K970653 | BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN ROAD | MCGAW PARK | IL | 60085 |
| K970663 | BAXTER HEALTHCARE CORP. |
1620 WAULKEGAN RD. | MCGAW PARK | IL | 60085-6730 |
| K994390 | GAMBRO HEALTHCARE |
1185 OAK ST. | LAKEWOOD | CO | 80215-4498 |
| K023615 | GAMBRO RENAL PRODUCTS |
10810 W. COLLINS AVE. | LAKEWOOD | CO | 80215 |
| K970648 | RENAL SYSTEMS, INC. |
14605 28TH AVENUE NORTH | MINNEAPOLIS | MN | 55447 |
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