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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 K953530
Device Name DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A
Applicant
Biosound, Inc.
7990 Castleway Dr.
P.O. Box 50867
Indianapolis,  IN  46250
Applicant Contact WAYNE NETHERCUTT
Correspondent
Biosound, Inc.
7990 Castleway Dr.
P.O. Box 50867
Indianapolis,  IN  46250
Correspondent Contact WAYNE NETHERCUTT
Regulation Number892.1560
Classification Product Code
IYO  
Date Received07/27/1995
Decision Date 04/08/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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