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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K837063
Device Name BIOSOUND SURGISCAN, ULTRASOUND IMAGING SYSTEM
Applicant
Biosound, Inc.
6405 Castleway Ct.
P.O. Box 50867
Indianapolis,  IN  46250
Correspondent
Biosound, Inc.
6405 Castleway Ct.
P.O. Box 50867
Indianapolis,  IN  46250
Date Received01/17/1983
Decision Date 04/04/1983
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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