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FDA 510(k) Application Details - K121716
Device Classification Name
Densitometer, Bone
More FDA Info for this Device
510(K) Number
K121716
Device Name
Densitometer, Bone
Applicant
MEDIMAPS GROUP SA
18 CHEMIN DES AULX
PLAN LES OUATES 1228 CH
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Contact
CHRISTOPHE LELONG
Other 510(k) Applications for this Contact
Regulation Number
892.1170
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Classification Product Code
KGI
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More FDA Info for this Product Code
Date Received
06/11/2012
Decision Date
10/05/2012
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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