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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K023430
Device Name UF BRACHYTHERAPY STAND
Applicant
University of Florida
5610 Wisconsin Ave., #304
Chevy Chase,  MD  20815
Applicant Contact PATSY J TRISLER
Correspondent
University of Florida
5610 Wisconsin Ave., #304
Chevy Chase,  MD  20815
Correspondent Contact PATSY J TRISLER
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
KXK  
Date Received10/11/2002
Decision Date 06/24/2003
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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