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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 K024363
Device Name NEXUS INJECTION SITE (NIS), MODEL NIS-1
Applicant
NEXUS MEDICAL, LLC
11428 LOSTWOOD LN.
SUITE B
RALEIGH,  NC  27614
Applicant Contact JAMIE ABOURCHED
Correspondent
NEXUS MEDICAL, LLC
11428 LOSTWOOD LN.
SUITE B
RALEIGH,  NC  27614
Correspondent Contact JAMIE ABOURCHED
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/31/2002
Decision Date 02/19/2003
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
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