The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Peritoneal Dial. Tita. Cath Adapter & Locking Cap.
| Device ID | K894783 |
| 510k Number | K894783 |
| Device Name: | PERITONEAL DIAL. TITA. CATH ADAPTER & LOCKING CAP |
| Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
| Applicant | BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073 |
| Contact | Robert L Wilkinson |
| Correspondent | Robert L Wilkinson BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073 |
| Product Code | KDJ |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-27 |
| Decision Date | 1989-09-07 |