Clearance Summary
HM-0970 received FDA 510(k) clearance under submission number K932720, sponsored by Hill-Med, Inc.. 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 1993-09-07.
- Submission: K932720
- Applicant / Sponsor: Hill-Med, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4700
- Decision date: 1993-09-07
Classification & Regulation
This clearance is catalogued under FDA product code HRM and 21 CFR 878.4700, within the General, Plastic Surgery review panel as a Class I device.