The following data is part of a premarket notification filed by Nxstage Medical, Inc. with the FDA for Streamline Airless System Set With Pre-attached Dialyzer.
| Device ID | K113023 |
| 510k Number | K113023 |
| Device Name: | STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST., 5TH FLOOR Lawrence, MA 01843 |
| Contact | Mary Lou Stroumbos |
| Correspondent | Mary Lou Stroumbos NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST., 5TH FLOOR Lawrence, MA 01843 |
| Product Code | KDI |
| Subsequent Product Code | FJK |
| Subsequent Product Code | KOC |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-11 |
| Decision Date | 2012-12-21 |
| Summary: | summary |