Clearance Summary
MAMOSPAT received FDA 510(k) clearance under submission number K935608, sponsored by E.V.S. Tool & Die Co., 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 1994-05-17.
- Submission: K935608
- Applicant / Sponsor: E.V.S. Tool & Die Co., Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1710
- Decision date: 1994-05-17
Classification & Regulation
This clearance is catalogued under FDA product code IZH and 21 CFR 892.1710, within the Radiology review panel as a Class II device.