510(k) BK140203
- Device
- 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
- Applicant
- Biosafe SA
- 510(k) number
- BK140203
- Product code
- OAO
- Decision
- Substantially Equivalent (SE)
- Decision date
- 2015-02-13
- Date received
- 2014-11-20
- Regulation
- 864.9900
- Classification name
- Cord Blood Processing System And Storage Container
- Medical specialty
- 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
- Review panel
- 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
- Clearance type
- 510(k) Special
- Third party reviewed
- No
Legacy Summary#
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FDA Review#
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