Clearance Summary
H-H SHUNT INTRODUCER received FDA 510(k) clearance under submission number K853368, 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 1985-09-06.
- Submission: K853368
- Applicant / Sponsor: Holter-Hausner Intl.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.4545
- Decision date: 1985-09-06
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.