Clearance Summary
SEPRAGEL SINUS received FDA 510(k) clearance under submission number K012532, sponsored by Genzyme Corp.. 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 2001-10-30.
- Submission: K012532
- Applicant / Sponsor: Genzyme Corp.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4780
- Decision date: 2001-10-30
Classification & Regulation
This clearance is catalogued under FDA product code LYA and 21 CFR 874.4780, within the Ear, Nose, Throat review panel as a Class I device.