RENAL LINK
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 Renal Link.
Pre-market Notification Details
| Device ID | K990953 |
| 510k Number | K990953 |
| Device Name: | RENAL LINK |
| Classification | System, Dialysate Delivery, Semi-automatic, Peritoneal |
| Applicant | BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Contact | David E Curtin |
| Correspondent | David E Curtin BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD 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 | 1999-03-22 |
| Decision Date | 1999-06-18 |
| Summary: | summary |
Trademark Results [RENAL LINK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RENAL LINK 74705002 2118279 Dead/Cancelled |
Baxter International Inc. 1995-07-24 |
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