Clearance Summary
J -JAMSHIDI TYPE-BONE MARROW BIOPSY/ASPI received FDA 510(k) clearance under submission number K843830, sponsored by Popper & Sons, 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 1984-10-26.
- Submission: K843830
- Applicant / Sponsor: Popper & Sons, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1984-10-26
Classification & Regulation
This clearance is catalogued under FDA product code GDM and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.