The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for U9000 Plus Ultrafilter.
| Device ID | K211035 |
| 510k Number | K211035 |
| Device Name: | U9000 Plus Ultrafilter |
| Classification | Subsystem, Water Purification |
| Applicant | Baxter Healthcare Corporation 25212 W. Illinois Route 120 Round Lake, IL 60073 |
| Contact | Carina Pforr |
| Correspondent | Carina Pforr Baxter Healthcare Corporation 25212 W. Illinois Route 120 Round Lake, IL 60073 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-07 |
| Decision Date | 2021-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37332414126958 | K211035 | 000 |