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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, i.v. fluid transfer
510(k) Number K122265
Device Name VIALOK SINGLE VIAL ACCESS DEVICE VENTED
Original Applicant
YUKON MEDICAL, LLC
4819-400 emperor blvd
durham,  NC  27703
Regulation Number880.5440
Classification Product Code
LHI  
Date Received07/30/2012
Decision Date 08/14/2012
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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