510(k) DEN120022
- Device
- X-RAY ATTENUATING CREAM
- Applicant
- Bloxr Corporation
- 510(k) number
- DEN120022
- Product code
- PDK
- Decision
- Unknown (DENG)
- Decision date
- 2013-05-09
- Date received
- 2012-11-07
- Regulation
- 892.6510
- Classification name
- Cream For X-Ray Attenuation
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- RAI CHOWDHARY
- Address
- 960 W. Levoy Dr. Suite 100 Salt Lake City UT US 84123 84123
FDA Registration Numbers#
- 2523891
- 2245304
- 3009688745
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PDK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K133684 | ULTRABLOX | Bloxr Corporation | 2014-01-13 |