The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Homechoice Apd Set With Lineo Connector, Models 5c4469q, 5c4468q, 5c4531q, 5c8302q, 5c4599q.
| Device ID | K031676 |
| 510k Number | K031676 |
| Device Name: | HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q |
| Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
| Applicant | BAXTER HEALTHCARE CORP. 1620 WAUKEGAN RD., MPR-A2E Mcgaw Park, IL 60085 -6730 |
| Contact | David E Curtin |
| Correspondent | David E Curtin BAXTER HEALTHCARE CORP. 1620 WAUKEGAN RD., MPR-A2E Mcgaw Park, IL 60085 -6730 |
| Product Code | KDJ |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2003-05-30 |
| Decision Date | 2003-11-20 |
| Summary: | summary |