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FDA 510(k) Application Details - K211681
Device Classification Name
More FDA Info for this Device
510(K) Number
K211681
Device Name
EON
Applicant
Dominion Aesthetic Technologies, Inc.
2431 Aloma Avenue Suite 225
Winter Park, FL 32792 US
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Contact
Ahmed Mohammed
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Regulation Number
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Classification Product Code
PKT
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More FDA Info for this Product Code
Date Received
06/01/2021
Decision Date
03/30/2022
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
N
Expedited Review
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