Clearance Summary
DU PONT XENOLITE(TM) RADIATION PROTECTION APPAREL received FDA 510(k) clearance under submission number K896511, sponsored by E.I. Dupont DE Nemours & Co., 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 1989-12-22.
- Submission: K896511
- Applicant / Sponsor: E.I. Dupont DE Nemours & Co., Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.6500
- Decision date: 1989-12-22
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.