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FDA 510(k), K013705, ACT III VENTRICULAR CATHETER
FDA 510(k), K013705, ACT III VENTRICULAR CATHETER
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510(K) Number: K013705
Device Name: ACT III VENTRICULAR CATHETER
Manufacturer: INNERSPACE, INC.
Device Classification Name: device, monitoring, intracranial pressure
Regulation Number: 882.1620
Classification Product Code: GWM
Date Received: 11/08/2001
Decision Date: 09/09/2002
Regulation Medical Specialty: Neurology
Device Name: ACT III VENTRICULAR CATHETER
Manufacturer: INNERSPACE, INC.
Device Classification Name: device, monitoring, intracranial pressure
Regulation Number: 882.1620
Classification Product Code: GWM
Date Received: 11/08/2001
Decision Date: 09/09/2002
Regulation Medical Specialty: Neurology
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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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