Clearance Summary
ULTRACELL NEURO SPONGES received FDA 510(k) clearance under submission number K970328, sponsored by Ultracell Medical Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1997-04-21.
- Submission: K970328
- Applicant / Sponsor: Ultracell Medical Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4700
- Decision date: 1997-04-21
Classification & Regulation
This clearance is catalogued under FDA product code HBA and 21 CFR 882.4700, within the Neurology review panel as a Class II device.