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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 K984285
Device Name OSTEOGRAM BONE DENSITOMETER
Applicant
Compumed, Inc.
12300 Twinbrook Pkwy., Suite 625
Rockville,  MD  20852
Applicant Contact T WHIT ATHEY
Correspondent
Compumed, Inc.
12300 Twinbrook Pkwy., Suite 625
Rockville,  MD  20852
Correspondent Contact T WHIT ATHEY
Regulation Number892.1170
Classification Product Code
KGI  
Date Received12/01/1998
Decision Date 05/19/1999
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
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