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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 K961007
Device Name EXPERT SPINE MORPHOTIETRY REFERENCE
Applicant
Lunar Corp.
313 W. Beltline Hwy.
Madison,  WI  53713
Applicant Contact Gary Syring
Correspondent
Lunar Corp.
313 W. Beltline Hwy.
Madison,  WI  53713
Correspondent Contact Gary Syring
Regulation Number892.1170
Classification Product Code
KGI  
Date Received03/12/1996
Decision Date 07/25/1996
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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