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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 K926019
Device Name FORARM OPT/NORLAND XR SERIES X-RAY BONE DENSITOMET
Applicant
Norland Corp.
W6340 Hackbarth Rd.
Fort Atkinson,  WI  53538
Applicant Contact TERRY SCHWALENBERG
Correspondent
Norland Corp.
W6340 Hackbarth Rd.
Fort Atkinson,  WI  53538
Correspondent Contact TERRY SCHWALENBERG
Regulation Number892.1170
Classification Product Code
KGI  
Date Received11/30/1992
Decision Date 09/23/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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