Clearance Summary
PLASTIC-GUIDES received FDA 510(k) clearance under submission number K901842, sponsored by M & K Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1990-07-11.
- Submission: K901842
- Applicant / Sponsor: M & K Co.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.5650
- Decision date: 1990-07-11
Classification & Regulation
This clearance is catalogued under FDA product code IWJ and 21 CFR 892.5650, within the Radiology review panel as a Class I device.