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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 K052581
Device Name LUNAR IDXA
Applicant
Ge Medical Systems Ultrasound and Primary Care Dia
726 Heartland Trl.
Madison,  WI  53717
Applicant Contact JAMES P RASKOB
Correspondent
Ge Medical Systems Ultrasound and Primary Care Dia
726 Heartland Trl.
Madison,  WI  53717
Correspondent Contact JAMES P RASKOB
Regulation Number892.1170
Classification Product Code
KGI  
Date Received09/20/2005
Decision Date 10/20/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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