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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 K910342
Device Name SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
Applicant
Medison Co., Ltd.
148 Yang Duk Won-Ri, Nam-Myun,
Hong Chun-Kun
Kang Won-Do,  KR
Applicant Contact ROBERT D WAXHAM
Correspondent
Medison Co., Ltd.
148 Yang Duk Won-Ri, Nam-Myun,
Hong Chun-Kun
Kang Won-Do,  KR
Correspondent Contact ROBERT D WAXHAM
Regulation Number892.1560
Classification Product Code
IYO  
Date Received01/28/1991
Decision Date 08/19/1991
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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