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FDA 510(k) Application Details - K230898
Device Classification Name
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510(K) Number
K230898
Device Name
FLUOBEAM« LX Red
Applicant
Fluoptics Sas
44 rue des berges
Grenoble 38000 FR
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Contact
Marion Boudet
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Regulation Number
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Classification Product Code
QDG
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Date Received
03/31/2023
Decision Date
07/28/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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