510(k) K133684
K133684 is an FDA 510(k) premarket notification submitted by Bloxr Corporation for the device "ULTRABLOX". The FDA issued a decision of Substantially Equivalent on January 13, 2014. The device falls under product code PDK (Cream For X-Ray Attenuation), a Class II device regulated under 21 CFR 892.6510. Bloxr Corporation has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 2014
- Date Received
- December 2, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cream For X-Ray Attenuation
- Device Class
- Class II
- Regulation Number
- 892.6510
- Review Panel
- RA
- Submission Type
The x-ray attenuating cream is intended for use as a radiation shield. It is intended to be applied to the user's hand before donning gloves, or it may be applied on a gloved hand, followed by donning a second glove. The X-ray attenuating cream is intended to be used during medical procedures where its necessary for hands to be exposed to radiation to offer some degree of protection from radiation exposure.