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FDA 510(k) Application Details - K081515
Device Classification Name
Catheter, Umbilical Artery
More FDA Info for this Device
510(K) Number
K081515
Device Name
Catheter, Umbilical Artery
Applicant
NEOMED, INC.
717 LAKEGLEN DR.
SUWANEE, GA 30024 US
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Contact
PENNY NORTHCUTT
Other 510(k) Applications for this Contact
Regulation Number
880.5200
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Classification Product Code
FOS
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More FDA Info for this Product Code
Date Received
05/30/2008
Decision Date
07/21/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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