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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name shunt, central nervous system and components
510(k) Number K161605
Device Name Smart External Drain (SED) System
Applicant
AQUEDUCT CRITICAL CARE, INC.
11822 NORTH CREEK PARKWAY NORTH
SUITE 110
Bothell,  WA  98011
Applicant Contact Thomas Clement
Correspondent
AQUEDUCT CRITICAL CARE, INC.
11822 NORTH CREEK PARKWAY NORTH
SUITE 110
Bothell,  WA  98011
Correspondent Contact Thomas Clement
Regulation Number882.5550
Classification Product Code
JXG  
Date Received06/10/2016
Decision Date 10/27/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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