Clearance Summary
CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 received FDA 510(k) clearance under submission number K021479, sponsored by Heinz Kurz GmbH Medizintechnik. The device was reviewed via the Special premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2002-05-21.
- Submission: K021479
- Applicant / Sponsor: Heinz Kurz GmbH Medizintechnik
- Clearance pathway: Special
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3450
- Decision date: 2002-05-21
Classification & Regulation
This clearance is catalogued under FDA product code ETB and 21 CFR 874.3450, within the Ear, Nose, Throat review panel as a Class II device.