Clearance Summary
MODIFIED INTENDED USE OF MONOJECT BONE MARROW NEED received FDA 510(k) clearance under submission number K883014, sponsored by Sherwood Medical Co.. 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 1988-07-28.
- Submission: K883014
- Applicant / Sponsor: Sherwood Medical Co.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1988-07-28
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.