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FDA 510(k) Application Details - K092930
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K092930
Device Name
Set, Administration, Intravascular
Applicant
NEXUS MEDICAL, LLC
11315 STRANG LINE ROAD
LENEXA, KS 66215 US
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Contact
HEATHER TURNER
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/22/2009
Decision Date
03/10/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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