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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 K843922
Device Name OSTEON BONE MINERAL ANALYZER
Applicant
Osteon, Inc.
410 Kilani Ave., Suite 202
P.O. Box 968
Wahiawa,  HI  96786
Applicant Contact PHILIP J MANLY
Correspondent
Osteon, Inc.
410 Kilani Ave., Suite 202
P.O. Box 968
Wahiawa,  HI  96786
Correspondent Contact PHILIP J MANLY
Regulation Number892.1170
Classification Product Code
KGI  
Date Received10/05/1984
Decision Date 04/02/1985
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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