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FDA 510(k) Application Details - K974083
Device Classification Name
Stopcock, I.V. Set
More FDA Info for this Device
510(K) Number
K974083
Device Name
Stopcock, I.V. Set
Applicant
OHMEDA MEDICAL
100 MOUNTAIN AVE.
MURRAY HILL, NJ 07974-2005 US
Other 510(k) Applications for this Company
Contact
JING ZHANG
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
10/29/1997
Decision Date
01/13/1998
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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