NAVARRE PERCUTANEOUS ACCESS SET

Accessories, Catheter

NAVARRE BIOMEDICAL LTD.

The following data is part of a premarket notification filed by Navarre Biomedical Ltd. with the FDA for Navarre Percutaneous Access Set.

Pre-market Notification Details

Device IDK942315
510k NumberK942315
Device Name:NAVARRE PERCUTANEOUS ACCESS SET
ClassificationAccessories, Catheter
Applicant NAVARRE BIOMEDICAL LTD. 705 TOWER DR. Hamel,  MN  55340
ContactGregg S Sutton
CorrespondentGregg S Sutton
NAVARRE BIOMEDICAL LTD. 705 TOWER DR. Hamel,  MN  55340
Product CodeKGZ  
CFR Regulation Number878.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-05-13
Decision Date1994-07-08

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