FDA 510(k), K082988, MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT

FDA 510(k), K082988, MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT

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510(K) Number: K082988
Device Name: MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT
Manufacturer: LYNN LUEDERS
Device Classification Name: Accessories, Cleaning, For Endoscope
Regulation Number: FEB
Classification Product Code: KXA
Date Received: 10/07/2008
Decision Date: 02/13/2009
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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