The following data is part of a premarket notification filed by Lifenet Health with the FDA for Allograft Mis Delivery System.
| Device ID | K201338 |
| 510k Number | K201338 |
| Device Name: | Allograft MIS Delivery System |
| Classification | Syringe, Piston |
| Applicant | LifeNet Health 1864 Concert Drive Virginia Beach, VA 23453 |
| Contact | Brittany Beasley |
| Correspondent | Brittany Beasley LifeNet Health 1864 Concert Drive Virginia Beach, VA 23453 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-20 |
| Decision Date | 2020-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889858628402 | K201338 | 000 |
| 00889858625203 | K201338 | 000 |
| 00889858628419 | K201338 | 000 |
| 00889858640244 | K201338 | 000 |