FDA 510(k), K031555, SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM

FDA 510(k), K031555, SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM

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510(K) Number: K031555
Device Name: SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM
Manufacturer: LISA M BOYLE
Device Classification Name: Monitor, Pressure, Intracompartmental
Regulation Number: LXC
Classification Product Code: KXA
Date Received: 05/19/2003
Decision Date: 07/08/2003
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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