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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Coupling, Ultrasound
510(k) Number K020956
Device Name VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA
Applicant
MICROTEK MEDICAL, INC.
602 LEHMBERG RD.
COLUMBUS,  MS  39702
Applicant Contact THOMAS BONNER
Correspondent
MICROTEK MEDICAL, INC.
602 LEHMBERG RD.
COLUMBUS,  MS  39702
Correspondent Contact THOMAS BONNER
Regulation Number892.1570
Classification Product Code
MUI  
Date Received03/25/2002
Decision Date 05/16/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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