FDA 510(k) Application Details - K111329

Device Classification Name Table, Physical Therapy, Multi Function

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510(K) Number K111329
Device Name Table, Physical Therapy, Multi Function
Applicant NUGA MEDICAL CO., LTD
77325 JOYCE WAY
ECHO, OR 97826 US
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Contact CHARLIE MACK
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Regulation Number 890.5880

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Classification Product Code JFB
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Date Received 05/11/2011
Decision Date 09/06/2011
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 Y
Expedited Review



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