Clearance Summary
MEGABEAM FIBER OPTIC DELIVERY SYSTEM received FDA 510(k) clearance under submission number K946336, sponsored by Hogan & Hartson. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1995-02-10.
- Submission: K946336
- Applicant / Sponsor: Hogan & Hartson
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 1995-02-10
Classification & Regulation
This clearance is catalogued under FDA product code GEX and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.