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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 K003141
Device Name UBM PLUS, MODEL P45
Applicant
PARADIGM MEDICAL INDUSTRIES, INC.
2355 SOUTH 1070 WEST
SALT LAKE CITY,  UT  84119
Applicant Contact TRACY S BEST
Correspondent
PARADIGM MEDICAL INDUSTRIES, INC.
2355 SOUTH 1070 WEST
SALT LAKE CITY,  UT  84119
Correspondent Contact TRACY S BEST
Regulation Number892.1560
Classification Product Code
IYO  
Date Received10/10/2000
Decision Date 12/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
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