The following data is part of a premarket notification filed by Nxstage Medical, Inc. with the FDA for Modification To: Nxstage Pureflow-b Solution.
| Device ID | K053286 |
| 510k Number | K053286 |
| Device Name: | MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST., 5TH FLOOR Lawrence, MA 01843 |
| Contact | Norma Lemay |
| Correspondent | Norma Lemay NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST., 5TH FLOOR Lawrence, MA 01843 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-25 |
| Decision Date | 2005-12-22 |
| Summary: | summary |