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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, administration, intravascular
510(k) Number K120799
Device Name ARISURE NEUTRAL VALVE
Applicant
YUKON MEDICAL, LLC
4819-400 EMPEROR BLVD
DURHAM,  NC  27703
Applicant Contact CARL DUPPER
Correspondent
PHARMALINK TECHNICAL GROUP, LLC
20 F STREET, NW
WASHINGTON,  DC  20001
Correspondent Contact MARK JOB
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/16/2012
Decision Date 03/30/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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