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FDA 510(k) Application Details - K231474
Device Classification Name
More FDA Info for this Device
510(K) Number
K231474
Device Name
Erchonia Violet ZERONA« Z6 OTC
Applicant
Erchonia Corporation
650 Atlantis Rd.
Melbourne, FL 32904 US
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Contact
Travis Sammons
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Regulation Number
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Classification Product Code
OLI
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More FDA Info for this Product Code
Date Received
05/22/2023
Decision Date
07/21/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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