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FDA 510(k) Application Details - K210956
Device Classification Name
Cabinet,X-Ray System
More FDA Info for this Device
510(K) Number
K210956
Device Name
Cabinet,X-Ray System
Applicant
KUB Technologies, Inc.
111 Research Drive
Stratford, CT 06615 US
Other 510(k) Applications for this Company
Contact
Chester Lowe
Other 510(k) Applications for this Contact
Regulation Number
892.1680
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Classification Product Code
MWP
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More FDA Info for this Product Code
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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