The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Luer Access Injection Site.
| Device ID | K984060 |
| 510k Number | K984060 |
| Device Name: | LUER ACCESS INJECTION SITE |
| Classification | Set, Administration, Intravascular |
| Applicant | BAXTER HEALTHCARE CORP. CLINTEC NUTRITION CO. ROUTE 120 AND WILSON ROAD Round Lake, IL 60073 |
| Contact | Mary Ellen Snyder |
| Correspondent | Mary Ellen Snyder BAXTER HEALTHCARE CORP. CLINTEC NUTRITION CO. ROUTE 120 AND WILSON ROAD 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 | 1998-11-13 |
| Decision Date | 1999-07-26 |
| Summary: | summary |