Clearance Summary
HHI ELECTRIC CONSOLE #875-000 received FDA 510(k) clearance under submission number K922056, sponsored by H&H Instruments. 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 1992-09-18.
- Submission: K922056
- Applicant / Sponsor: H&H Instruments
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 1992-09-18
Classification & Regulation
This clearance is catalogued under FDA product code HWE and 21 CFR 878.4820, within the General, Plastic Surgery review panel as a Class I device.