The following data is part of a premarket notification filed by Nxstage Medical, Inc. with the FDA for Nxstage Dialysate Concentrate, Model Rfc-100.
| Device ID | K013655 |
| 510k Number | K013655 |
| Device Name: | NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100 |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST. SUITE 501 S. Lawrence, MA 01843 |
| Contact | Karen St. Onge |
| Correspondent | Karen St. Onge NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST. SUITE 501 S. Lawrence, MA 01843 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-06 |
| Decision Date | 2002-02-04 |
| Summary: | summary |