FDA 510(k), K080845, ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM

FDA 510(k), K080845, ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM

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510(K) Number: K080845
Device Name: ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM
Manufacturer: LAVENIA FORD
Device Classification Name: Apparatus, Suction, Ward Use, Portable, Ac-Powered
Regulation Number: JCX
Classification Product Code: KXA
Date Received: 03/26/2008
Decision Date: 04/30/2008
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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