The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Homechoice/homechoice Pro Personal Cycler Peritoneal Dialysis System, Models 5c4471 And 5c8310.
| Device ID | K053512 |
| 510k Number | K053512 |
| Device Name: | HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310 |
| Classification | System, Peritoneal, Automatic Delivery |
| 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 | FKX |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-16 |
| Decision Date | 2006-02-16 |
| Summary: | summary |