FDA 510(k) Application Details - K243644

Device Classification Name Table, Physical Therapy, Multi Function

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510(K) Number K243644
Device Name Table, Physical Therapy, Multi Function
Applicant CERAGEM Co, Ltd.
10, Jeongja 1-gil, Seonggeo-eup, Seobuk-gu
Cheonan-si 31045 KR
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Contact Sangmin Lee
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Regulation Number 890.5880

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Classification Product Code JFB
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Date Received 11/26/2024
Decision Date 01/08/2025
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K243644


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