Clearance Summary
SILHOUETTE, MODEL 1000.01 received FDA 510(k) clearance under submission number K070426, sponsored by Aranz Medical Limited. 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 2007-06-29.
- Submission: K070426
- Applicant / Sponsor: Aranz Medical Limited
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4160
- Decision date: 2007-06-29
Classification & Regulation
This clearance is catalogued under FDA product code FXN and 21 CFR 878.4160, within the General, Plastic Surgery review panel as a Class I device.