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FDA 510(k) Application Details - K083765
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K083765
Device Name
Set, Administration, Intravascular
Applicant
MEDEGEN MEDICAL MANUFACTURING SERVICES
930 WANAMAKER AVE.
ONTARIO, CA 91761 US
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Contact
MATTHEW FRIED
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
12/18/2008
Decision Date
12/30/2008
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
Y
Expedited Review
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