The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Solution Set For Epidural Use.
| Device ID | K161323 |
| 510k Number | K161323 |
| Device Name: | Solution Set For Epidural Use |
| Classification | Set, Administration, Intravascular |
| Applicant | BAXTER HEALTHCARE CORPORATION 32650 N. WILSON ROAD Round Lake, IL 60073 |
| Contact | Tiffany Lin |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-05-11 |
| Decision Date | 2016-11-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412563713 | K161323 | 000 |