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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 K873296
Device Name DPX BONE DENSITOMETER
Applicant
Lunar Radiation Corp.
313 W. Beltline Hwy.
Madison,  WI  53713
Applicant Contact MAZESS, PHD
Correspondent
Lunar Radiation Corp.
313 W. Beltline Hwy.
Madison,  WI  53713
Correspondent Contact MAZESS, PHD
Regulation Number892.1170
Classification Product Code
KGI  
Date Received08/17/1987
Decision Date 06/06/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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