FDA 510(k) Application Details - K210956

Device Classification Name Cabinet,X-Ray System

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510(K) Number K210956
Device Name Cabinet,X-Ray System
Applicant KUB Technologies, Inc.
111 Research Drive
Stratford, CT 06615 US
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Contact Chester Lowe
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Regulation Number 892.1680

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Classification Product Code MWP
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Date Received 03/30/2021
Decision Date 08/31/2021
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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