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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 K080976
Device Name NEXUS I.V. FLUID TRANSFER DEVICE
Applicant
NEXUS MEDICAL, LLC
11315 STRANG LINE ROAD
LENEXA,  KS  66215
Applicant Contact LARRY SMITH
Correspondent
NEXUS MEDICAL, LLC
11315 STRANG LINE ROAD
LENEXA,  KS  66215
Correspondent Contact LARRY SMITH
Regulation Number880.5440
Classification Product Code
LHI  
Date Received04/07/2008
Decision Date 11/10/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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