NAVARRE BIOMEDICAL TIP-LOCKING DRAINAGE CATHETERS

Catheter, Irrigation

NAVARRE BIOMEDICAL LTD.

The following data is part of a premarket notification filed by Navarre Biomedical Ltd. with the FDA for Navarre Biomedical Tip-locking Drainage Catheters.

Pre-market Notification Details

Device IDK933600
510k NumberK933600
Device Name:NAVARRE BIOMEDICAL TIP-LOCKING DRAINAGE CATHETERS
ClassificationCatheter, Irrigation
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 CodeGBX  
CFR Regulation Number878.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-07-27
Decision Date1994-03-28

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