FDA 510(k) Application Details - K110078

Device Classification Name Negative Pressure Wound Therapy Powered Suction Pump

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510(K) Number K110078
Device Name Negative Pressure Wound Therapy Powered Suction Pump
Applicant DEVON MEDICAL PRODUCTS, INC.
1100 FIRST AVENUE, SUITE 100
KING OF PRUSSIA, PA 19406 US
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Contact RUTH WU
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Regulation Number 878.4780

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Classification Product Code OMP
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Date Received 01/11/2011
Decision Date 02/10/2012
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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