Clearance Summary
BONE MARROW BIOPSY TRAY received FDA 510(k) clearance under submission number K912074, sponsored by Manan Medical Products, 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 1991-08-28.
- Submission: K912074
- Applicant / Sponsor: Manan Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1991-08-28
Classification & Regulation
This clearance is catalogued under FDA product code GAA and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.