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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 K113398
Device Name NEXUS TKO-6, LUER-ACTIVATED DEVICE
Applicant
Nexus Medical, LLC
11315 Strang Line Rd.
Lenexa,  KS  66215
Applicant Contact HEATHER TURNER
Correspondent
Nexus Medical, LLC
11315 Strang Line Rd.
Lenexa,  KS  66215
Correspondent Contact HEATHER TURNER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/17/2011
Decision Date 04/18/2012
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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