The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Vial-mate Reconstitution Device (2b8071).
| Device ID | K973654 |
| 510k Number | K973654 |
| Device Name: | VIAL-MATE RECONSTITUTION DEVICE (2B8071) |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073 |
| Contact | Tamima Itani |
| Correspondent | Tamima Itani BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-25 |
| Decision Date | 1997-10-24 |
| Summary: | summary |