The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Buretrol Solution Sets.
| Device ID | K984381 |
| 510k Number | K984381 |
| Device Name: | BURETROL SOLUTION SETS |
| Classification | Set, Administration, Intravascular |
| Applicant | BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
| Contact | Judy Kannenberg |
| Correspondent | Judy Kannenberg BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-08 |
| Decision Date | 1999-02-19 |
| Summary: | summary |