Clearance Summary
H-H NERVE ROOT RETRACTOR received FDA 510(k) clearance under submission number K822048, sponsored by Holter-Hausner Intl.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1982-07-22.
- Submission: K822048
- Applicant / Sponsor: Holter-Hausner Intl.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.4535
- Decision date: 1982-07-22
Classification & Regulation
This clearance is catalogued under FDA product code HAO and 21 CFR 882.4535, within the Neurology review panel as a Class I device.