Clearance Summary
IMPAX 5000 received FDA 510(k) clearance under submission number K934386, sponsored by Heraeus Kulzer, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1994-01-05.
- Submission: K934386
- Applicant / Sponsor: Heraeus Kulzer, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.2020
- Decision date: 1994-01-05
Classification & Regulation
This clearance is catalogued under FDA product code LMD and 21 CFR 892.2020, within the Radiology review panel as a Class I device.