Clearance Summary
ELECTRONIC UNIT received FDA 510(k) clearance under submission number K832887, sponsored by Surgi-Quip Inc.U. 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 1983-10-04.
- Submission: K832887
- Applicant / Sponsor: Surgi-Quip Inc.U
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4700
- Decision date: 1983-10-04
Classification & Regulation
This clearance is catalogued under FDA product code EPT and 21 CFR 878.4700, within the General, Plastic Surgery review panel as a Class I device.