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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 K952822
Device Name SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G
Applicant
Shimadzu Corp.
1 Nishinokyo-Kuwabaracho
Nakaygo-Ku
Kyoto City 604 Japan,  JP
Applicant Contact MASARU ADACHI
Correspondent
Shimadzu Corp.
1 Nishinokyo-Kuwabaracho
Nakaygo-Ku
Kyoto City 604 Japan,  JP
Correspondent Contact MASARU ADACHI
Regulation Number892.1700
Classification Product Code
IZO  
Date Received06/20/1995
Decision Date 07/12/1995
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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