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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 K964307
Device Name EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS
Applicant
Lunar Corp.
313 W. Beltline Highway
Madison,  WI  53713
Applicant Contact KENNETH D BUROKER
Correspondent
Lunar Corp.
313 W. Beltline Highway
Madison,  WI  53713
Correspondent Contact KENNETH D BUROKER
Regulation Number892.1170
Classification Product Code
KGI  
Date Received10/29/1996
Decision Date 04/16/1997
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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