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FDA 510(k) Application Details - K222176
Device Classification Name
More FDA Info for this Device
510(K) Number
K222176
Device Name
BoneView
Applicant
Gleamer
5 Avenue du GΘnΘral de Gaulle
Saint MandΘ 94160 FR
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Contact
Antoine Tournier
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Regulation Number
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Classification Product Code
QBS
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More FDA Info for this Product Code
Date Received
07/22/2022
Decision Date
03/02/2023
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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