Clearance Summary
CEMENT AND BONE REMOVAL KIT received FDA 510(k) clearance under submission number K961759, sponsored by Maillefer Instruments S.A.. 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 1996-06-13.
- Submission: K961759
- Applicant / Sponsor: Maillefer Instruments S.A.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 1996-06-13
Classification & Regulation
This clearance is catalogued under FDA product code HWE and 21 CFR 878.4820, within the General, Plastic Surgery review panel as a Class I device.