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FDA 510(k) Application Details - K971844
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K971844
Device Name
Set, Administration, Intravascular
Applicant
MCKINLEY, INC.
4080 YOUNGFIELD ST.
WHEAT RIDGE, CO 80033 US
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Contact
BRIAN D ZDEB
Other 510(k) Applications for this Contact
Regulation Number
880.5440
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Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/19/1997
Decision Date
01/23/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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