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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 K972882
Device Name APOLLO
Applicant
Norland Corp.
West 6340 Hackbarth Rd.
Fort Atkinson,  WI  53538
Applicant Contact TERRY SCHWALENGERG
Correspondent
Norland Corp.
31 Gordan Rd.
Piscataway,  NJ  08854
Correspondent Contact John Monahan
Regulation Number892.1170
Classification Product Code
KGI  
Date Received08/05/1997
Decision Date 10/31/1997
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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