Clearance Summary
LIGHTCAST II CARBIDE BLADE received FDA 510(k) clearance under submission number K760605, sponsored by Merck, Sharp & Dohme. 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 1976-10-05.
- Submission: K760605
- Applicant / Sponsor: Merck, Sharp & Dohme
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1976-10-05
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.