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510(k) DEN120022

X-RAY ATTENUATING CREAM by Bloxr Corporation — Product Code PDK

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
May 9, 2013
Date Received
November 7, 2012
Clearance Type
Direct
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.

Other clearances by Bloxr Corporation

  • K133684 — ULTRABLOX (January 13, 2014)
  • K110900 — DISPOSABLE THYROID COLLAR (June 24, 2011)

Other clearances for product code PDK

  • K133684 — ULTRABLOX (January 13, 2014)