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FDA 510(k) Applications for Medical Device:
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| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K971015 | AMERICAN HEALTH CARE SYSTEMS, INC. |
3350 RIDGELAKE AVE., SUITE 255 | METAIRIE | LA | 70002 |
| K033262 | GAMBRO RENAL PRODUCTS |
10810 W. COLLINS AVE. | LAKEWOOD | CO | 80215 |
| K133807 | GAMBRO RENAL PRODUCTS, INC. |
14143 DENVER WEST PARKWAY | LAKEWOOD | CO | 80401 |
| K113313 | GAMBRO RENAL PRODUCTS, INC. |
14143 DENVER WEST PARKWAY | LAKEWOOD | CO | 80401 |
| K984546 | HEMOCLEANSE, INC. |
2700 KENT AVE. | WEST LAFAYETTE | IN | 47906 |
| K953751 | HEMOCLEANSE, INC. |
2700 KENT AVE. | WEST LAFAYETTE | IN | 47906 |
| K992196 | HEMOCLEANSE, INC. |
2700 KENT AVE. | WEST LAFAYETTE | IN | 47906 |