Clearance Summary
CHISEL (OSTEOTOME, GOUGE, ETC.) received FDA 510(k) clearance under submission number K864775, sponsored by New England Surgical Instrument Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1987-02-12.
- Submission: K864775
- Applicant / Sponsor: New England Surgical Instrument Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1987-02-12
Classification & Regulation
This clearance is catalogued under FDA product code EMM and 21 CFR 872.4565, within the Dental review panel as a Class I device.