Clearance Summary
MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME received FDA 510(k) clearance under submission number K874298, sponsored by Engineered Orthopedic Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1988-02-04.
- Submission: K874298
- Applicant / Sponsor: Engineered Orthopedic Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4460
- Decision date: 1988-02-04
Classification & Regulation
This clearance is catalogued under FDA product code HBL and 21 CFR 882.4460, within the Neurology review panel as a Class II device.