FDA 510(k) Application Details - K140634

Device Classification Name Negative Pressure Wound Therapy Powered Suction Pump

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510(K) Number K140634
Device Name Negative Pressure Wound Therapy Powered Suction Pump
Applicant Devon Medical, Inc.
1100 First Avenue, Suite 202
King of Prussia, PA 19406 US
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Contact Steve XU
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Regulation Number 878.4780

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Classification Product Code OMP
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Date Received 03/12/2014
Decision Date 09/19/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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