Clearance Summary
IP-16 received FDA 510(k) clearance under submission number K980301, sponsored by Servizi Medico Estetici Italinai Srl.. 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 1998-03-24.
- Submission: K980301
- Applicant / Sponsor: Servizi Medico Estetici Italinai Srl.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4780
- Decision date: 1998-03-24
Classification & Regulation
This clearance is catalogued under FDA product code BTA and 21 CFR 878.4780, within the General, Plastic Surgery review panel as a Class II device.