NORFOLK MEDICAL PERITONEAL-ACCESS PORT

Device, Peritoneal Access, Subcutaneous, Implanted

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 Peritoneal-access Port.

Pre-market Notification Details

Device IDK854593
510k NumberK854593
Device Name:NORFOLK MEDICAL PERITONEAL-ACCESS PORT
ClassificationDevice, Peritoneal Access, Subcutaneous, Implanted
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 CodeLMQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-11-18
Decision Date1986-02-04

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