Clearance Summary
STAT PAK received FDA 510(k) clearance under submission number K943820, sponsored by Magnum Instruments, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1994-11-02.
- Submission: K943820
- Applicant / Sponsor: Magnum Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1994-11-02
Classification & Regulation
This clearance is catalogued under FDA product code EKJ and 21 CFR 872.4565, within the Dental review panel as a Class I device.