FDA 510(k), K111949, AC WOUND TREATMENT SYSTEM

FDA 510(k), K111949, AC WOUND TREATMENT SYSTEM

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510(K) Number: K111949
Device Name: AC WOUND TREATMENT SYSTEM
Manufacturer: E J SMITH
Device Classification Name: Negative Pressure Wound Therapy Powered Suction Pump
Regulation Number: OMP
Classification Product Code: KXA
Date Received: 07/08/2011
Decision Date: 06/29/2012
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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