Clearance Summary
PISTORMATIC received FDA 510(k) clearance under submission number K790104, sponsored by Zelby, Burstein, Hartman & Burstein. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1979-05-14.
- Submission: K790104
- Applicant / Sponsor: Zelby, Burstein, Hartman & Burstein
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6920
- Decision date: 1979-05-14
Classification & Regulation
This clearance is catalogued under FDA product code KZH and 21 CFR 880.6920, within the General Hospital review panel as a Class II device.