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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 K802181
Device Name WISCONSIN BONE MINERAL ANALYZER
Applicant
Lunar Radiation Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Lunar Radiation Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number892.1170
Classification Product Code
KGI  
Date Received09/09/1980
Decision Date 12/31/1980
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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