Clearance Summary
CHERMEL BONE CHISELS received FDA 510(k) clearance under submission number K842824, sponsored by Cher Mel Corp.. 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 1984-08-02.
- Submission: K842824
- Applicant / Sponsor: Cher Mel Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 1984-08-02
Classification & Regulation
This clearance is catalogued under FDA product code KDG and 21 CFR 878.4820, within the General, Plastic Surgery review panel as a Class I device.