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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomographic
510(k) Number K013620
Device Name MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION
Applicant
Medstone Intl., Inc.
100 Columbia
Suite 100
Aliso Viejo,  CA  92656 -4114
Applicant Contact RON BERGESON
Correspondent
Medstone Intl., Inc.
100 Columbia
Suite 100
Aliso Viejo,  CA  92656 -4114
Correspondent Contact RON BERGESON
Regulation Number892.1740
Classification Product Code
IZF  
Date Received11/05/2001
Decision Date 01/22/2002
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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