The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Iv Fat Emulsion Administration Sets.
| Device ID | K172544 |
| 510k Number | K172544 |
| Device Name: | IV Fat Emulsion Administration Sets |
| Classification | Set, Administration, Intravascular |
| Applicant | Baxter Healthcare Corporation 32650 N. Wilson Road Round Lake, IL 60073 |
| Contact | Jill M. Laack |
| Correspondent | Jill M. Laack Baxter Healthcare Corporation 32650 N. Wilson Road Round Lake, IL 60073 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-23 |
| Decision Date | 2017-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412565946 | K172544 | 000 |
| 50085412565625 | K172544 | 000 |