Clearance Summary
KS-78 VERTICAL WALL CASSETTE HOLDER received FDA 510(k) clearance under submission number K790742, sponsored by Pausch Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1979-04-26.
- Submission: K790742
- Applicant / Sponsor: Pausch Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1880
- Decision date: 1979-04-26
Classification & Regulation
This clearance is catalogued under FDA product code IXY and 21 CFR 892.1880, within the Radiology review panel as a Class I device.