The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Infusor Small Volume Elastomeric Infusion Devices.
| Device ID | K062457 |
| 510k Number | K062457 |
| Device Name: | INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES |
| Classification | Pump, Infusion, Elastomeric |
| Applicant | BAXTER HEALTHCARE CORPORATION 1620 WAUKEGAN RD. Mcgaw Park, IL 60085 |
| Contact | Nanette Hedden |
| Correspondent | Nanette Hedden BAXTER HEALTHCARE CORPORATION 1620 WAUKEGAN RD. Mcgaw Park, IL 60085 |
| Product Code | MEB |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-23 |
| Decision Date | 2006-09-21 |
| Summary: | summary |