Clearance Summary
AART GLUTEAL IMPLANT received FDA 510(k) clearance under submission number K021839, sponsored by Aesthetic and Reconstructive Technologies, 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 2002-07-16.
- Submission: K021839
- Applicant / Sponsor: Aesthetic and Reconstructive Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3620
- Decision date: 2002-07-16
Classification & Regulation
This clearance is catalogued under FDA product code MIB and 21 CFR 874.3620, within the Ear, Nose, Throat review panel as a Class II device.