Clearance Summary
HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONS received FDA 510(k) clearance under submission number K881276, sponsored by Ime Co. , Ltd.. 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 1988-05-04.
- Submission: K881276
- Applicant / Sponsor: Ime Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.5350
- Decision date: 1988-05-04
Classification & Regulation
This clearance is catalogued under FDA product code KCW and 21 CFR 878.5350, within the General, Plastic Surgery review panel as a Class I device.