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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 K933471
Device Name SHIMADZU X-RAY HIGH VOLTAGE GENERATOR AUD150G
Applicant
Shimadzu Corp.
1 Nishinokyo-Kuwabaracho
Nakaygo-Ku
Kyoto City 604 Japan,  JP
Applicant Contact HIROSHI I SHIHARA
Correspondent
Shimadzu Corp.
1 Nishinokyo-Kuwabaracho
Nakaygo-Ku
Kyoto City 604 Japan,  JP
Correspondent Contact HIROSHI I SHIHARA
Regulation Number892.1700
Classification Product Code
IZO  
Date Received07/15/1993
Decision Date 11/24/1993
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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