FDA 510(k) Application Details - K142956

Device Classification Name Negative Pressure Wound Therapy Powered Suction Pump

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510(K) Number K142956
Device Name Negative Pressure Wound Therapy Powered Suction Pump
Applicant Integrated Healing Technologies
103 Forrest Crossing Blvd, Suite 103
Franklin, TN 37064 US
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Contact Ian Baird
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Regulation Number 878.4780

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Classification Product Code OMP
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Date Received 10/14/2014
Decision Date 02/24/2015
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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