FDA 510(k), K111380, NEURON MAX SYSTEM

FDA 510(k), K111380, NEURON MAX SYSTEM

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510(K) Number: K111380
Device Name: NEURON MAX SYSTEM
Manufacturer: MICHAELA MAHL
Device Classification Name: Catheter, Percutaneous
Regulation Number: DQY
Classification Product Code: KXA
Date Received: 05/16/2011
Decision Date: 07/19/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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