Clearance Summary
I.M PROBES received FDA 510(k) clearance under submission number K802951, sponsored by Hogan & Hartson. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1980-12-17.
- Submission: K802951
- Applicant / Sponsor: Hogan & Hartson
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 1980-12-17
Classification & Regulation
This clearance is catalogued under FDA product code HXB and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.