510(k) K133684
- Device
- ULTRABLOX
- Applicant
- BLOXR CORPORATION
- 510(k) number
- K133684
- Product code
- PDK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-01-13
- Date received
- 2013-12-02
- Regulation
- 892.6510
- Classification name
- Cream For X-ray Attenuation
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RAI CHOWDHARY
- Address
- 960 Levoy Dr. Salt Lake City UT US 84123 84123
FDA Registration Numbers#
- 2523891
- 2245304
- 3009688745
Source Documents#
Other 510(k) Records For Product Code PDK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN120022 | X-RAY ATTENUATING CREAM | Bloxr Corporation | 2013-05-09 |
Legacy Summary#
summary
FDA Review#
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