The following data is part of a premarket notification filed by Md3 Llc with the FDA for Preferx Delivery System.
| Device ID | K210997 |
| 510k Number | K210997 |
| Device Name: | PreferX Delivery System |
| Classification | Syringe, Piston |
| Applicant | MD3 LLC 3650 Coral Ridge Drive Suite 107 Coral Springs, FL 33065 |
| Contact | Mary Ann Greenawalt |
| Correspondent | Mary Ann Greenawalt MD3 LLC 3650 Coral Ridge Drive Suite 107 Coral Springs, FL 33065 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-02 |
| Decision Date | 2021-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B992151000 | K210997 | 000 |