NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS

Port & Catheter, Implanted, Subcutaneous, Intravascular

NORFOLK MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Norfolk Medical Products, Inc. with the FDA for Norfolk Medical-sportport-family Of Ports.

Pre-market Notification Details

Device IDK112713
510k NumberK112713
Device Name:NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS
ClassificationPort & Catheter, Implanted, Subcutaneous, Intravascular
Applicant NORFOLK MEDICAL PRODUCTS, INC. 7350 NORTH RIDGEWAY Skokie,  IL  60076
ContactMichael Dalton
CorrespondentMichael Dalton
NORFOLK MEDICAL PRODUCTS, INC. 7350 NORTH RIDGEWAY Skokie,  IL  60076
Product CodeLJT  
CFR Regulation Number880.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-19
Decision Date2011-10-27
Summary:summary

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