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FDA 510(k) Application Details - DEN230067
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN230067
Device Name
Chronos«
Applicant
Germitec
19 rue Vauban
Bordeaux 33000 FR
Other 510(k) Applications for this Company
Contact
Vincent Gardes
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
SCS
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More FDA Info for this Product Code
Date Received
09/28/2023
Decision Date
08/28/2024
Decision
DENG -
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
FDA Source Information for DEN230067
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