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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, Obstetric
510(k) Number K872265
Device Name ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE.
Applicant
Labsonics, Inc.
P.O. Box 337
236 E. Washington St.
Mooresville,  IN  46158
Applicant Contact N. T SANGHVI
Correspondent
Labsonics, Inc.
P.O. Box 337
236 E. Washington St.
Mooresville,  IN  46158
Correspondent Contact N. T SANGHVI
Regulation Number884.2960
Classification Product Code
HGL  
Date Received06/11/1987
Decision Date 01/04/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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