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FDA 510(k) Application Details - K230905
Device Classification Name
More FDA Info for this Device
510(K) Number
K230905
Device Name
OrthoPulse 2.0E (OPi2E-100)
Applicant
Biolux Technology GmbH
Neubaugasse 31
Absdorf 3462 AT
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Contact
Daniela Penn
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Regulation Number
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Classification Product Code
PLH
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Date Received
03/31/2023
Decision Date
06/09/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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