MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS

Laparoscope, General & Plastic Surgery

MEDTRONIC XOMED, INC.

The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Microfrance Laparoscopic Manual Surgical Instruments.

Pre-market Notification Details

Device IDK080257
510k NumberK080257
Device Name:MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS
ClassificationLaparoscope, General & Plastic Surgery
Applicant MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216
ContactJayme Wilson
CorrespondentJayme Wilson
MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-01-31
Decision Date2008-05-22
Summary:summary

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