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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name transducer, ultrasonic, diagnostic
510(k) Number K992155
Device Name VOLUSION SMALL PARTS TRANSDUCER, MODEL S-VNW 5-10, VOLUSION ABDOMINAL TRANSDUCER, MODEL S-VAW 4-7
Applicant
MEDISON AMERICA, INC.
6616 OWENS DR.
PLEASANTON,  CA  94588
Applicant Contact MICHAELA MAHL
Correspondent
TUV PRODUCT SERVICE, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact CAROLE STAMP
Regulation Number892.1570
Classification Product Code
ITX  
Date Received06/25/1999
Decision Date 07/08/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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