The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Pain-mate Pain Management System With Dual Port 1+1, 2+2, Models 2c1718, 2c1719.
| Device ID | K021274 |
| 510k Number | K021274 |
| Device Name: | PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719 |
| Classification | Pump, Infusion, Elastomeric |
| Applicant | BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
| Contact | Vivki L Drews |
| Correspondent | Vivki L Drews BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
| Product Code | MEB |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-22 |
| Decision Date | 2002-05-17 |
| Summary: | summary |