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FDA 510(k) Application Details - K213748
Device Classification Name
Stimulator, Muscle, Powered, For Muscle Conditioning
More FDA Info for this Device
510(K) Number
K213748
Device Name
Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant
Lutronic Corporation
Lutronic Center, 219, Sowon-Ro
Deogyang-Gu, Goyang-si 410220 KR
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Contact
Haewon Park
Other 510(k) Applications for this Contact
Regulation Number
890.5850
More FDA Info for this Regulation Number
Classification Product Code
NGX
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More FDA Info for this Product Code
Date Received
11/30/2021
Decision Date
10/14/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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