Clearance Summary
I.M. RETROGRADE BLADES received FDA 510(k) clearance under submission number K810045, 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 1981-02-12.
- Submission: K810045
- Applicant / Sponsor: Hogan & Hartson
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 1981-02-12
Classification & Regulation
This clearance is catalogued under FDA product code GFA and 21 CFR 878.4820, within the General, Plastic Surgery review panel as a Class I device.