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FDA 510(k) Application Details - K223673
Device Classification Name
More FDA Info for this Device
510(K) Number
K223673
Device Name
Surgeon Controlled Arm
Applicant
Levita Magnetics International Corp.
4055-A Campbell Avenue
Menlo Park, CA 94025 US
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Contact
Alberto Rodriguez-Navarro, MD
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Regulation Number
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Classification Product Code
PNL
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More FDA Info for this Product Code
Date Received
12/07/2022
Decision Date
08/04/2023
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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