FDA 510(k) Application Details - K240168

Device Classification Name Table, Physical Therapy, Multi Function

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510(K) Number K240168
Device Name Table, Physical Therapy, Multi Function
Applicant Nuga Medical Co., Ltd.
185, Jiraeul-ro, Jijeong-myeon
Wonju-si 26355 KR
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Contact Jun Woo Lee
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Regulation Number 890.5880

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Classification Product Code JFB
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Date Received 01/22/2024
Decision Date 09/12/2024
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

FDA Source Information for K240168


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