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FDA 510(k) Application Details - K220519
Device Classification Name
More FDA Info for this Device
510(K) Number
K220519
Device Name
Erchonia Zerona Z-Bed
Applicant
Erchonia Corporation
650 Atlantis Road
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
02/23/2022
Decision Date
03/24/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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