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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 K993337
Device Name APOLLO MULTI-RACIAL REFERENCE POPULATION
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 Received10/05/1999
Decision Date 05/16/2000
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
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