Clearance Summary
FLUOROSCOPE BAND BAG received FDA 510(k) clearance under submission number K861785, sponsored by Medi-Plast Intl., 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 1986-06-13.
- Submission: K861785
- Applicant / Sponsor: Medi-Plast Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 1986-06-13
Classification & Regulation
This clearance is catalogued under FDA product code JAA and 21 CFR 892.1650, within the Radiology review panel as a Class II device.