Clearance Summary
X-RAY DRAPES received FDA 510(k) clearance under submission number K923099, sponsored by Hydro-Med Products, 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 1992-10-15.
- Submission: K923099
- Applicant / Sponsor: Hydro-Med Products, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.6500
- Decision date: 1992-10-15
Classification & Regulation
This clearance is catalogued under FDA product code IWQ and 21 CFR 892.6500, within the Radiology review panel as a Class I device.