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FDA 510(k) Application Details - K142399
Device Classification Name
More FDA Info for this Device
510(K) Number
K142399
Device Name
DualCap IV Pole Strips(Disinfectant Caps for Male Luers)
Applicant
CATHETER CONNECTIONS, INC.
2455 E Parleys Way - Suite 150
Salt Lake City, UT 84109 US
Other 510(k) Applications for this Company
Contact
Donald d Soloman
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QBP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/27/2014
Decision Date
11/19/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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