NEEDLE/CANNULA

General Surgery Tray

TRI-MED SPECIALTIES, INC.

The following data is part of a premarket notification filed by Tri-med Specialties, Inc. with the FDA for Needle/cannula.

Pre-market Notification Details

Device IDK950574
510k NumberK950574
Device Name:NEEDLE/CANNULA
ClassificationGeneral Surgery Tray
Applicant TRI-MED SPECIALTIES, INC. P.O. BOX 23306 Overland Park,  KS  66223
ContactMike Knoth
CorrespondentMike Knoth
TRI-MED SPECIALTIES, INC. P.O. BOX 23306 Overland Park,  KS  66223
Product CodeLRO  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent - Kit With Drugs (SEKD)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-01-27
Decision Date1995-02-24

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