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FDA 510(k), K161605, Smart External Drain (SED) System
FDA 510(k), K161605, Smart External Drain (SED) System
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510(K) Number: K161605
Device Name: Smart External Drain (SED) System
Manufacturer: AQUEDUCT CRITICAL CARE, INC.
Device Classification Name: Shunt, Central Nervous System And Components
Regulation Number: 882.5550
Classification Product Code: JXG
Date Received: 06/10/2016
Decision Date: 10/27/2016
Regulation Medical Specialty: Neurology
Device Name: Smart External Drain (SED) System
Manufacturer: AQUEDUCT CRITICAL CARE, INC.
Device Classification Name: Shunt, Central Nervous System And Components
Regulation Number: 882.5550
Classification Product Code: JXG
Date Received: 06/10/2016
Decision Date: 10/27/2016
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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