Clearance Summary
PERSONNA PLUS SAFETY SCALPEL SYSTEM received FDA 510(k) clearance under submission number K032242, sponsored by Omi Manufacturing Pty., Ltd.. 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 2003-09-23.
- Submission: K032242
- Applicant / Sponsor: Omi Manufacturing Pty., Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 2003-09-23
Classification & Regulation
This clearance is catalogued under FDA product code GES and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.