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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 K874854
Device Name GPS/WGPS/PREVIEW GP
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 Number892.1560
Classification Product Code
IYO  
Date Received11/27/1987
Decision Date 08/25/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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