VASCULAR ACCESS PORT CHANGES IN MATER

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 Vascular Access Port Changes In Mater.

Pre-market Notification Details

Device IDK840788
510k NumberK840788
Device Name:VASCULAR ACCESS PORT CHANGES IN MATER
ClassificationPort & Catheter, Implanted, Subcutaneous, Intravascular
Applicant NORFOLK MEDICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeLJT  
CFR Regulation Number880.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-01-06
Decision Date1984-04-24

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