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FDA 510(k), K131966, TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEM
FDA 510(k), K131966, TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEM
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510(K) Number: K131966
Device Name: TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEM
Manufacturer: TWIN STAR MEDICAL, INC.
Device Classification Name: monitor, pressure, intracompartmental
Regulation Number:
Classification Product Code: LXC
Date Received: 06/28/2013
Decision Date: 02/07/2014
Regulation Medical Specialty:
Device Name: TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEM
Manufacturer: TWIN STAR MEDICAL, INC.
Device Classification Name: monitor, pressure, intracompartmental
Regulation Number:
Classification Product Code: LXC
Date Received: 06/28/2013
Decision Date: 02/07/2014
Regulation Medical Specialty:
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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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