RENALSOFT
System, Dialysate Delivery, Semi-automatic, Peritoneal
BAXTER HEALTHCARE CORP.
The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Renalsoft.
Pre-market Notification Details
| Device ID | K061515 |
| 510k Number | K061515 |
| Device Name: | RENALSOFT |
| Classification | System, Dialysate Delivery, Semi-automatic, Peritoneal |
| Applicant | BAXTER HEALTHCARE CORP. 1620 WAUKEGAN RD Mcgaw Park, IL 60085 |
| Contact | David E Curtin |
| Correspondent | David E Curtin BAXTER HEALTHCARE CORP. 1620 WAUKEGAN RD Mcgaw Park, IL 60085 |
| Product Code | KPF |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-01 |
| Decision Date | 2006-09-11 |
| Summary: | summary |
Trademark Results [RENALSOFT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RENALSOFT 76435133 2818176 Live/Registered |
Baxter International Inc. 2002-07-29 |
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