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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 K972053
Device Name PIXI YOUNG ADULT REFERENC POPULATION FOR OS CALCIS AND FOREARM
Applicant
Lunar Corp.
313 W. Beltline Highway
Madison,  WI  53713
Applicant Contact KENNETH D BURCKER
Correspondent
Lunar Corp.
313 W. Beltline Highway
Madison,  WI  53713
Correspondent Contact KENNETH D BURCKER
Regulation Number892.1170
Classification Product Code
KGI  
Date Received06/02/1997
Decision Date 08/08/1997
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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