Clearance Summary
BUCKYS MODELS YMB-15A, YMB-15B AND YMB-15C received FDA 510(k) clearance under submission number K895034, sponsored by Yamato Medical 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 1989-11-15.
- Submission: K895034
- Applicant / Sponsor: Yamato Medical Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1880
- Decision date: 1989-11-15
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.