FDA 510(k) Application Details - K002113

Device Classification Name Densitometer, Bone

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510(K) Number K002113
Device Name Densitometer, Bone
Applicant MINDWAYS SOFTWARE, INC.
282 SECOND ST., 4TH FL.
SAN FRANCISCO, CA 94105-3130 US
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Contact CHRISTOPHER CANN
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Regulation Number 892.1170

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Classification Product Code KGI
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Date Received 06/07/2000
Decision Date 12/04/2001
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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