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FDA 510(k) Application Details - K050906
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K050906
Device Name
Set, Administration, Intravascular
Applicant
VITALCARE GROUP, INC.
8935 NW 27TH STREET
MIAMI, FL 33172 US
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Contact
MICHAEL MCAVENIA
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/11/2005
Decision Date
08/23/2005
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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