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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 K011917
Device Name ADVANCED HIP ASSESSMENT SOFTWARE
Applicant
Ge Lunar Corp.
726 Heartland Trail
Madison,  WI  53717
Applicant Contact JAMES P RASKOB
Correspondent
Ge Lunar Corp.
726 Heartland Trail
Madison,  WI  53717
Correspondent Contact JAMES P RASKOB
Regulation Number892.1170
Classification Product Code
KGI  
Date Received06/20/2001
Decision Date 08/03/2001
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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