The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Sterile Saline For Catheter Care.
| Device ID | K974397 |
| 510k Number | K974397 |
| Device Name: | STERILE SALINE FOR CATHETER CARE |
| Classification | Catheter And Tip, Suction |
| Applicant | BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
| Contact | Marcia Marconi |
| Correspondent | Marcia Marconi BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
| Product Code | JOL |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-21 |
| Decision Date | 1998-02-10 |
| Summary: | summary |