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FDA 510(k) Application Details - K222012
Device Classification Name
More FDA Info for this Device
510(K) Number
K222012
Device Name
FAQ 101
Applicant
Foreo, Inc.
1525 E. Pama Lane
Las Vegas, NV 89119 US
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Contact
Laura Hoshue
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Regulation Number
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Classification Product Code
PAY
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More FDA Info for this Product Code
Date Received
07/08/2022
Decision Date
04/05/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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