ENDOLINK TRUE MOVEMENT SYSTEM

Laparoscope, General & Plastic Surgery

NOVARE SURGICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Novare Surgical Systems, Inc. with the FDA for Endolink True Movement System.

Pre-market Notification Details

Device IDK043541
510k NumberK043541
Device Name:ENDOLINK TRUE MOVEMENT SYSTEM
ClassificationLaparoscope, General & Plastic Surgery
Applicant NOVARE SURGICAL SYSTEMS, INC. 3924 CASCADE BEACH ROAD Lutsen,  MN  55612
ContactGregory Mathison
CorrespondentGregory Mathison
NOVARE SURGICAL SYSTEMS, INC. 3924 CASCADE BEACH ROAD Lutsen,  MN  55612
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-12-22
Decision Date2005-03-10
Summary:summary

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