Clearance Summary
PERSONNEL PROTECTIVE SHIELD received FDA 510(k) clearance under submission number K871502, sponsored by Cis-Us, 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 1987-05-08.
- Submission: K871502
- Applicant / Sponsor: Cis-Us, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.6500
- Decision date: 1987-05-08
Classification & Regulation
This clearance is catalogued under FDA product code KPY and 21 CFR 892.6500, within the Radiology review panel as a Class I device.