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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 K992125
Device Name XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46
Applicant
Norland Medical Systems, Inc.
W-6340 Hackbarth Rd.
Fort Atkinson,  WI  53538
Applicant Contact TERRY SCHWALENBERG
Correspondent
Norland Medical Systems, Inc.
31 Gordan Rd.
Piscataway,  NJ  08854
Correspondent Contact John Monahan
Regulation Number892.1170
Classification Product Code
KGI  
Date Received06/23/1999
Decision Date 11/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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