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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Imager, Ultrasonic Obstetric-Gynecologic
510(k) Number K900505
Device Name SONOACE 88 PORTABLE ULTRASOUND SCANNER
Applicant
Medison Co., Ltd.
602 St. Andrews Dr.
Media,  PA  19063
Applicant Contact ROBERT D WAXHAM
Correspondent
Medison Co., Ltd.
602 St. Andrews Dr.
Media,  PA  19063
Correspondent Contact ROBERT D WAXHAM
Regulation Number884.2225
Classification Product Code
HEM  
Date Received02/02/1990
Decision Date 08/10/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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