Clearance Summary
HEMSTATS received FDA 510(k) clearance under submission number K844152, sponsored by I M, 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 1984-11-07.
- Submission: K844152
- Applicant / Sponsor: I M, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1984-11-07
Classification & Regulation
This clearance is catalogued under FDA product code HRQ and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.