FDA 510(k) Application Details - K002500

Device Classification Name Densitometer, Bone

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510(K) Number K002500
Device Name Densitometer, Bone
Applicant PRONOSCO A/S
555 13TH ST.
WASHINGTON, DC 20004 US
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Contact JONATHAN KAHAN
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Regulation Number 892.1170

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Classification Product Code KGI
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Date Received 08/14/2000
Decision Date 10/23/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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