The following data is part of a premarket notification filed by Medsafety Solutions Llc with the FDA for Female Luer Lock Cap.
| Device ID | K200425 |
| 510k Number | K200425 |
| Device Name: | Female Luer Lock Cap |
| Classification | Set, Administration, Intravascular |
| Applicant | MedSafety Solutions LLC 7012 S. Revere Pkwy, Suite 120 Centennial, CO 80112 |
| Contact | Rich Weiskopf |
| Correspondent | Prithul Bom 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 | 2020-02-20 |
| Decision Date | 2020-10-29 |