The following data is part of a premarket notification filed by Nxstage Medical, Inc. with the FDA for Leak Detection Sensor And Tray Accessory Kit.
| Device ID | K081043 |
| 510k Number | K081043 |
| Device Name: | LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| 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 | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-14 |
| Decision Date | 2008-07-07 |
| Summary: | summary |