FDA 510(k) Application Details - K143362

Device Classification Name Negative Pressure Wound Therapy Powered Suction Pump

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510(K) Number K143362
Device Name Negative Pressure Wound Therapy Powered Suction Pump
Applicant Devon Medical Products
1100 First Avenue, Suite 202
King of Prussia, PA 19406 US
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Contact John Siegel
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Regulation Number 878.4780

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Classification Product Code OMP
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Date Received 11/24/2014
Decision Date 02/03/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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