Clearance Summary
FORAMATRON IV received FDA 510(k) clearance under submission number K950857, sponsored by Parkell, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 1995-04-20.
- Submission: K950857
- Applicant / Sponsor: Parkell, Inc.
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 1995-04-20
Classification & Regulation
This clearance is catalogued under FDA product code LQY , within the Unknown review panel as a device.