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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 K033224
Device Name HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER
Applicant
Hologic, Inc.
35 Crosby Dr.
Bedford,  MA  01730
Applicant Contact DANIEL F PHELAN
Correspondent
Hologic, Inc.
35 Crosby Dr.
Bedford,  MA  01730
Correspondent Contact DANIEL F PHELAN
Regulation Number892.1170
Classification Product Code
KGI  
Date Received10/06/2003
Decision Date 11/05/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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