FDA 510(k) Application Details - K153054

Device Classification Name Table, Physical Therapy, Multi Function

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510(K) Number K153054
Device Name Table, Physical Therapy, Multi Function
Applicant NUGA MEDICAL CO., LTD
185, JIRAEUL-RO, JIJEONG-MYEON
Wonju 220-821 KR
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Contact JONG SOO LEE
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Regulation Number 890.5880

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Classification Product Code JFB
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Date Received 10/20/2015
Decision Date 02/05/2016
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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