K201338 is an FDA 510(k) clearance for the Allograft MIS Delivery System. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Lifenet Health (Virginia Beach, US). The FDA issued a Cleared decision on July 13, 2020, 54 days after receiving the submission on May 20, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K201338 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 2020 |
| Decision Date | July 13, 2020 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |