The following data is part of a premarket notification filed by Baxter Healthcare Corporation - Renal Division with the FDA for Neutral Luer Activated Device And Extension Sets With Neutral Luer Activated Device.
| Device ID | K120443 |
| 510k Number | K120443 |
| Device Name: | NEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH NEUTRAL LUER ACTIVATED DEVICE |
| Classification | Set, Administration, Intravascular |
| Applicant | BAXTER HEALTHCARE CORPORATION - RENAL DIVISION 1620 WAUKEGAN ROAD BUILDING R Mcgaw Park, IL 60085 |
| Contact | Nanette Hedden |
| Correspondent | Nanette Hedden BAXTER HEALTHCARE CORPORATION - RENAL DIVISION 1620 WAUKEGAN ROAD BUILDING R Mcgaw Park, IL 60085 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-14 |
| Decision Date | 2012-05-22 |
| Summary: | summary |