Clearance Summary
RINN PROTECTIVE X-RAY APRON AND PROTECTIVE COLLAR received FDA 510(k) clearance under submission number K913621, sponsored by Rinn Dental Products. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1991-09-27.
- Submission: K913621
- Applicant / Sponsor: Rinn Dental Products
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.6500
- Decision date: 1991-09-27
Classification & Regulation
This clearance is catalogued under FDA product code EAJ and 21 CFR 892.6500, within the Radiology review panel as a Class I device.