The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for All-in-one Container Cat#'s 2b8114,2b8124, 2b8134, 2b8144, 2b8102, 2b8152, 2b8112, 2b8117m 2b8122, 2b8132, 2b8142, 2b712.
| Device ID | K983294 |
| 510k Number | K983294 |
| Device Name: | ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712 |
| Classification | Container, I.v. |
| Applicant | BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
| Contact | Linda Coleman |
| Correspondent | Linda Coleman BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-21 |
| Decision Date | 1998-11-03 |
| Summary: | summary |