meddevicedb.com FDA Device Reference

X-RAY ATTENUATING CREAM

DEN120022 Class II Direct
Decision Date
2013-05-09
Sponsor / Applicant
Bloxr Corporation

Technical Specification

510(k) Submission ID DEN120022
Product Code PDK
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.6510
Decision Date 2013-05-09
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

X-RAY ATTENUATING CREAM received FDA 510(k) clearance under submission number DEN120022, sponsored by Bloxr Corporation. The device was reviewed via the Direct premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2013-05-09.

Classification & Regulation

This clearance is catalogued under FDA product code PDK and 21 CFR 892.6510, within the Radiology review panel as a Class II device.