FDA 510(k) Application Details - K992246

Device Classification Name Densitometer, Bone

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510(K) Number K992246
Device Name Densitometer, Bone
Applicant IMAGE ANALYSIS, INC.
1380 BURKESVILLE ST.
COLUMBIA, KY 42728 US
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Contact BEN ARNOLD
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Regulation Number 892.1170

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Classification Product Code KGI
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Date Received 07/06/1999
Decision Date 09/03/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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