The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Vial-mate Adaptor.
| Device ID | K142600 |
| 510k Number | K142600 |
| Device Name: | VIAL-MATE Adaptor |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | BAXTER HEALTHCARE CORPORATION 32650 N. WILSON ROAD, Round Lake, IL 60073 |
| Contact | Gary Chumbimune |
| Correspondent | Gary Chumbimune BAXTER HEALTHCARE CORPORATION 32650 N. WILSON ROAD, Round Lake, IL 60073 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-15 |
| Decision Date | 2014-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412027383 | K142600 | 000 |