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FDA 510(k) Application Details - K964435
Device Classification Name
Stopcock, I.V. Set
More FDA Info for this Device
510(K) Number
K964435
Device Name
Stopcock, I.V. Set
Applicant
ICU MEDICAL, INC.
951 CALLE AMANECER
SAN CLEMENTE, CA 92673 US
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Contact
RICHARD WATERS
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
11/05/1996
Decision Date
04/02/1997
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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