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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: 05/19/2003
Date Received: 07/08/2003
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM
Manufacturer: LISA M BOYLE
Device Classification Name: Monitor, Pressure, Intracompartmental
Regulation Number: LXC
Classification Product Code: 05/19/2003
Date Received: 07/08/2003
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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