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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 K931996
Device Name MODEL PDEXA BONE DENSITOMETER
Original Applicant
NORLAND CORP.
w6340 hackbarth rd.
fort atkinson,  WI  53538
Original Contact terry schwalenberg
Regulation Number892.1170
Classification Product Code
KGI  
Date Received04/23/1993
Decision Date 02/01/1995
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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