The following data is part of a premarket notification filed by Fidia Farmaceutici S.p.a. with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration Follow Fda En Español Search Fda Home Food Drugs Medical Devices .
| Device ID | BK180296 |
| 510k Number | BK180296 |
| Device Name: | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices |
| Classification | Platelet And Plasma Separator For Bone Graft Handling |
| Applicant | Fidia Farmaceutici S.p.A. via Ponte Della Fabbrica 3/a Abano Terme, Padua, 35031, IT |
| Product Code | ORG |
| CFR Regulation Number | 864.9245 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-13 |
| Decision Date | 2019-11-05 |