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FDA 510(k) Application Details - K082836
Device Classification Name
Stopcock, I.V. Set
More FDA Info for this Device
510(K) Number
K082836
Device Name
Stopcock, I.V. Set
Applicant
ICU MEDICAL, INC.
4455 ATHERTON DRIVE
SALT LAKE CITY, UT 84123 US
Other 510(k) Applications for this Company
Contact
NILOUFAR SAMIMI
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
FMG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/26/2008
Decision Date
02/25/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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