Clearance Summary
SPECTRUM DESIGNS PROFILE MALAR IMPLANT received FDA 510(k) clearance under submission number K980139, sponsored by Spectrum Designs, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1998-03-03.
- Submission: K980139
- Applicant / Sponsor: Spectrum Designs, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3550
- Decision date: 1998-03-03
Classification & Regulation
This clearance is catalogued under FDA product code LZK and 21 CFR 878.3550, within the General, Plastic Surgery review panel as a Class II device.