The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Solution Administration Set.
| Device ID | K981792 |
| 510k Number | K981792 |
| Device Name: | SOLUTION ADMINISTRATION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
| Contact | Mary Ellen Snyder |
| Correspondent | Mary Ellen Snyder 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 | 1998-05-21 |
| Decision Date | 1998-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412022951 | K981792 | 000 |