MEDTRONIC GRAFT DELIVERY SYRINGE

Syringe, Piston

MEDTRONIC SOFAMOR DANEK USA, INC.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Medtronic Graft Delivery Syringe.

Pre-market Notification Details

Device IDK062986
510k NumberK062986
Device Name:MEDTRONIC GRAFT DELIVERY SYRINGE
ClassificationSyringe, Piston
Applicant MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactEdward S Chin
CorrespondentEdward S Chin
MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-09-29
Decision Date2006-12-08
Summary:summary

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