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FDA 510(k) Application Details - K012429
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K012429
Device Name
Set, Administration, Intravascular
Applicant
APPLIED DIABETES RESEARCH, INCORPORATED
103 NOLEN LN.
CHAPEL HILL, NC 27516 US
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Contact
CHARLES H KYPER
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
FPA
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More FDA Info for this Product Code
Date Received
07/31/2001
Decision Date
11/06/2001
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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