Clearance Summary
HM-CRYO received FDA 510(k) clearance under submission number K940140, 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 1994-06-27.
- Submission: K940140
- Applicant / Sponsor: Hill-Med, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4350
- Decision date: 1994-06-27
Classification & Regulation
This clearance is catalogued under FDA product code GEH and 21 CFR 878.4350, within the General, Plastic Surgery review panel as a Class II device.