SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT

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 Subcutaneously Implanted Drug Delivery Depot.

Pre-market Notification Details

Device IDK871192
510k NumberK871192
Device Name:SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT
ClassificationPort & Catheter, Implanted, Subcutaneous, Intravascular
Applicant NORFOLK MEDICAL PRODUCTS, INC. 7307 N. RIDGEWAY Skokie,  IL  60076
ContactMichael J Dalton
CorrespondentMichael J Dalton
NORFOLK MEDICAL PRODUCTS, INC. 7307 N. RIDGEWAY Skokie,  IL  60076
Product CodeLJT  
CFR Regulation Number880.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-03-24
Decision Date1987-06-10

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