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FDA 510(k) Application Details - K060231
Device Classification Name
Stopcock, I.V. Set
More FDA Info for this Device
510(K) Number
K060231
Device Name
Stopcock, I.V. Set
Applicant
ELCAM MEDICAL A.C.A.L.
KIBBUTZ BAR-AM
D.N. MEROM HAGALIL 13860 IL
Other 510(k) Applications for this Company
Contact
TALI HAZAN
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
01/30/2006
Decision Date
04/13/2006
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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