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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 K080711
Device Name 1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION
Applicant
HOLOGIC, INC.
35 CROSBY DR.
BEDFORD,  MA  01730
Applicant Contact BRYAN COWELL
Correspondent
HOLOGIC, INC.
35 CROSBY DR.
BEDFORD,  MA  01730
Correspondent Contact BRYAN COWELL
Regulation Number892.1170
Classification Product Code
KGI  
Date Received03/13/2008
Decision Date 09/02/2008
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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