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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, High-Voltage, X-Ray, Diagnostic
510(k) Number K934967
Device Name SHIMADZU UD150L-R X-RAY HIGH VOLTAGE GENERATOR
Applicant
Shimadzu Corp.
20101 S. Vermont Ave.
Torrance,  CA  90502
Applicant Contact MICHAEL Y FISHBACK
Correspondent
Shimadzu Corp.
20101 S. Vermont Ave.
Torrance,  CA  90502
Correspondent Contact MICHAEL Y FISHBACK
Regulation Number892.1700
Classification Product Code
IZO  
Date Received10/15/1993
Decision Date 12/13/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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