Clearance Summary
H-H SUBGALEAL TROCAR received FDA 510(k) clearance under submission number K865075, 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 1987-01-13.
- Submission: K865075
- Applicant / Sponsor: Holter-Hausner Intl.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.4545
- Decision date: 1987-01-13
Classification & Regulation
This clearance is catalogued under FDA product code GYK and 21 CFR 882.4545, within the Neurology review panel as a Class I device.