FDA 510(k) Applications for Medical Device:
System, Dialysate Delivery, Single Patient
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K992255 | CSAM, INC. |
1890 14TH ST. | BETTENDORF | IA | 52722 |
| K003615 | ENVIRONMENTAL TEST SYSTEMS, INC. |
P.O. BOX 4659 | ELKHART | IN | 46514 |
| K021060 | FRESENIUS MEDICAL CARE NORTH AMERICA |
95 HAYDEN AVE. | LEXINGTON | MA | 02420-9192 |
| K955423 | FRESENIUS USA, INC. |
2637 SHADELANDS DR. | WALNUT CREEK | CA | 94598 |
| K964264 | INTEGRATED BIOMEDICAL TECHNOLOGY, INC. |
2931 MOOSE TRAIL | ELKHART | IN | 46514 |
| K953854 | INTEGRATED BIOMEDICAL TECHNOLOGY, INC. |
51819 WINDING WATERS LN. | ELKHART | IN | 46514 |
| K181991 | NxStage Medical, Inc |
350 Merrimack Street | Lawrence | MA | 01843 |
| K131739 | NXSTAGE MEDICAL, INC. |
350 Merrimack St | LAWRENCE | MA | 01843 |
| K130460 | NXSTAGE MEDICAL, INC. |
350 Merrimack St | LAWRENCE | MA | 01843 |
| K040074 | NXSTAGE MEDICAL, INC. |
439 SOUTH UNION ST., 5TH FLOOR | LAWRENCE | MA | 01843 |
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