Clearance Summary
QUADRASPHERE 30 TO 60 received FDA 510(k) clearance under submission number K113822, sponsored by Biosphere Medical, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2012-03-08.
- Submission: K113822
- Applicant / Sponsor: Biosphere Medical, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5950
- Decision date: 2012-03-08
Classification & Regulation
This clearance is catalogued under FDA product code HCG and 21 CFR 882.5950, within the Neurology review panel as a Class II device.