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FDA 510(k) Application Details - K954970
Device Classification Name
Stopcock, I.V. Set
More FDA Info for this Device
510(K) Number
K954970
Device Name
Stopcock, I.V. Set
Applicant
MEDEX, INC.
6250 SHIER RINGS RD.
DUBLIN, OH 40316 US
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Contact
JOHN C TOOMEY
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
10/30/1995
Decision Date
04/22/1996
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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