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FDA 510(k) Applications for Medical Device Product Code "FKR"
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| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K060296 | NXSTAGE MEDICAL, INC. | NXSTAGE DIALYSATE PREPARATION MODULE | 03/31/2006 |
| K043436 | NXSTAGE MEDICAL, INC. | NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 | 03/17/2005 |
| K140571 | NXSTAGE MEDICAL, INC. | NXSTAGE PUREFLOW SL | 05/15/2014 |
| K080919 | NXSTAGE MEDICAL, INC. | NXSTAGE PUREFLOW SL | 10/15/2008 |
| K111174 | NXSTAGE MEDICAL, INC. | NXSTAGE PUREFLOW SL | 09/19/2011 |