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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 K071233
Device Name XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM
Applicant
KUB TECHNOLOGIES, INC
543 LONG HILL AVENUE
SHELTON,  CT  06824
Applicant Contact JOSEPH M AZARY
Correspondent
KUB TECHNOLOGIES, INC
543 LONG HILL AVENUE
SHELTON,  CT  06824
Correspondent Contact JOSEPH M AZARY
Regulation Number892.1680
Classification Product Code
MWP  
Date Received05/03/2007
Decision Date 06/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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