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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Densitometer, Bone
510(k) Number K103730
Device Name GE LUNAR VISCERAL FAT SOFTWARE
Applicant
Ge Medical Systems Ultrasound and Primary Care Dia
3030 Ohmeda Dr.
Madison,  WI  53718
Applicant Contact CHRIS PAULIK
Correspondent
Ge Medical Systems Ultrasound and Primary Care Dia
3030 Ohmeda Dr.
Madison,  WI  53718
Correspondent Contact CHRIS PAULIK
Regulation Number892.1170
Classification Product Code
KGI  
Date Received12/21/2010
Decision Date 05/06/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Clinical Trials NCT00987298
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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