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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 K934040
Device Name THE OSTEOREPORT
Applicant
Woodson and Associates, LLC
2476 Burnt Leaf Ln.
Decatur,  GA  30033
Applicant Contact GRATTAN C WOODSON
Correspondent
Woodson and Associates, LLC
2476 Burnt Leaf Ln.
Decatur,  GA  30033
Correspondent Contact GRATTAN C WOODSON
Regulation Number892.1170
Classification Product Code
KGI  
Date Received08/18/1993
Decision Date 09/26/1994
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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