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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cabinet, X-Ray System
510(k) Number K210955
Device Name Kubtec Mozart Supra (XPERT 84) Radiography System
Applicant
Kub Technologies, Inc.
111 Research Dr.
Stratford,  CT  06615
Applicant Contact Chester Lowe
Correspondent
Kub Technologies, Inc.
111 Research Dr.
Stratford,  CT  06615
Correspondent Contact Chester Lowe
Regulation Number892.1680
Classification Product Code
MWP  
Date Received03/30/2021
Decision Date 09/20/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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