Clearance Summary
NK MEDICAL MICROMETER, MODEL MC001 received FDA 510(k) clearance under submission number K921266, sponsored by Nk Biotechnical Engineering Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1992-07-14.
- Submission: K921266
- Applicant / Sponsor: Nk Biotechnical Engineering Co.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4150
- Decision date: 1992-07-14
Classification & Regulation
This clearance is catalogued under FDA product code KTZ and 21 CFR 888.4150, within the Orthopedic review panel as a Class I device.