Clearance Summary
MACROPORE ENT RECONSTRUCTION FILM received FDA 510(k) clearance under submission number K012769, sponsored by Macropore Biosurgery, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2001-10-25.
- Submission: K012769
- Applicant / Sponsor: Macropore Biosurgery, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3620
- Decision date: 2001-10-25
Classification & Regulation
This clearance is catalogued under FDA product code NHB and 21 CFR 874.3620, within the Ear, Nose, Throat review panel as a Class II device.