FDA 510(k) Application Details - K213455

Device Classification Name

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510(K) Number K213455
Device Name ControlRad Select Model Z
Applicant ControlRad, Inc.
275 Scientific Drive NW #1100
Norcross, GA 30092 US
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Contact Chris Fair
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Regulation Number

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Classification Product Code OWB
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Date Received 10/26/2021
Decision Date 11/24/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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