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FDA 510(k) Application Details - K970524
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K970524
Device Name
Set, Administration, Intravascular
Applicant
FAULDING MEDICAL DEVICE CO.
8777 EAST VIA DE VENTURA,
SUITE 225
SCOTTSDALE, AZ 85258 US
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Contact
BRUCE CRANEY
Other 510(k) Applications for this Contact
Regulation Number
880.5440
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Classification Product Code
FPA
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More FDA Info for this Product Code
Date Received
02/11/1997
Decision Date
04/22/1997
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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