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FDA 510(k) Application Details - K023595
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K023595
Device Name
Set, Administration, Intravascular
Applicant
TUTA HEALTHCARE PTY LIMITED
318-332 BURNS BAY ROAD
LANE COVE
SYDNEY NSW 2066 AU
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Contact
OMID SOURESRAFIL
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
10/28/2002
Decision Date
12/18/2002
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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