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FDA 510(k) Application Details - K213455
Device Classification Name
More FDA Info for this Device
510(K) Number
K213455
Device Name
ControlRad Select Model Z
Applicant
ControlRad, Inc.
275 Scientific Drive NW #1100
Norcross, GA 30092 US
Other 510(k) Applications for this Company
Contact
Chris Fair
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Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OWB
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More FDA Info for this Product Code
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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