The following data is part of a premarket notification filed by Biosafe Sa 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 | BK140203 |
| 510k Number | BK140203 |
| 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 | Cord Blood Processing System And Storage Container |
| Applicant | Biosafe SA route Du Petit-eysins Eysins, Vaud, 1262, SZ |
| Product Code | OAO |
| CFR Regulation Number | 864.9900 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-20 |
| Decision Date | 2015-02-13 |