The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for Packpd Peritoneal Dialysis Urea Kinetic Modeling Software Program.
Device ID | K955762 |
510k Number | K955762 |
Device Name: | PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM |
Classification | System, Dialysate Delivery, Semi-automatic, Peritoneal |
Applicant | FRESENIUS USA, INC. 2637 SHADELANDS DR. Walnut Creek, CA 94598 |
Contact | Tom Folden |
Correspondent | Tom Folden FRESENIUS USA, INC. 2637 SHADELANDS DR. Walnut Creek, CA 94598 |
Product Code | KPF |
CFR Regulation Number | 876.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-12-18 |
Decision Date | 1996-07-31 |