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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sampler, amniotic fluid (amniocentesis tray)
510(k) Number K904583
Device Name SONO-VU US(TM)
Applicant
E-Z-EM, INC.
373 PLANTATION ST.
WORCESTER,  MA  01605
Applicant Contact GEORGANNE BROWN
Correspondent
E-Z-EM, INC.
373 PLANTATION ST.
WORCESTER,  MA  01605
Correspondent Contact GEORGANNE BROWN
Regulation Number884.1550
Classification Product Code
HIO  
Date Received10/09/1990
Decision Date 06/24/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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