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FDA 510(k) Application Details - K213957
Device Classification Name
More FDA Info for this Device
510(K) Number
K213957
Device Name
Demetra Dermatoscope BDEM-01
Applicant
Barco NV
President Kennedypark 35
Kortrijk 8500 BE
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Contact
Imke Storm
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Regulation Number
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Classification Product Code
PSN
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Date Received
12/17/2021
Decision Date
03/11/2022
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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