The following data is part of a premarket notification filed by Nxstage Medical, Inc. with the FDA for Nxstage Dialysate Preparation Module.
Device ID | K060296 |
510k Number | K060296 |
Device Name: | NXSTAGE DIALYSATE PREPARATION MODULE |
Classification | Subsystem, Proportioning |
Applicant | NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST. SUITE 501 Lawrence, MA 01843 |
Contact | Norma Lemay |
Correspondent | Norma Lemay NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST. SUITE 501 Lawrence, MA 01843 |
Product Code | FKR |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-02-06 |
Decision Date | 2006-03-31 |
Summary: | summary |