Clearance Summary
THE DE SOUTTER M193 REAMER received FDA 510(k) clearance under submission number K930784, sponsored by De Soutter Medical, 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 1993-10-27.
- Submission: K930784
- Applicant / Sponsor: De Soutter Medical, Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 1993-10-27
Classification & Regulation
This clearance is catalogued under FDA product code HSZ and 21 CFR 878.4820, within the General, Plastic Surgery review panel as a Class I device.