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FDA 510(k) Application Details - K102385
Device Classification Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
More FDA Info for this Device
510(K) Number
K102385
Device Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant
NORFOLK MEDICAL PRODUCTS, INC.
7350 NORTH RIDGEWAY
SKOKIE, IL 60076 US
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Contact
MICHAEL J DALTON
Other 510(k) Applications for this Contact
Regulation Number
880.5965
More FDA Info for this Regulation Number
Classification Product Code
LJT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/23/2010
Decision Date
01/14/2011
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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