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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 K982267
Device Name DPX-RX BONE DENSITOMETER
Applicant
LUNAR CORP.
313 WEST BELTLINE HIGHWAY
MADISON,  WI  53713
Applicant Contact KENNETH D BUROKER
Correspondent
LUNAR CORP.
313 WEST BELTLINE HIGHWAY
MADISON,  WI  53713
Correspondent Contact KENNETH D BUROKER
Regulation Number892.1170
Classification Product Code
KGI  
Date Received06/29/1998
Decision Date 08/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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