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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 K030962
Device Name DPX SERIES BRAVO DUO BONE DENSITOMETER
Applicant
GE LUNAR CORP.
726 HEARTLAND TRAIL
MADISON,  WI  53717
Applicant Contact JAMES P RASKOB
Correspondent
GE LUNAR CORP.
726 HEARTLAND TRAIL
MADISON,  WI  53717
Correspondent Contact JAMES P RASKOB
Regulation Number892.1170
Classification Product Code
KGI  
Date Received03/27/2003
Decision Date 07/25/2003
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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