DISPOSABLE LAPAROSCOPIC ELECTRODE, DISPOSABLE LAPAROSCOPIC ELECTRODE

Electrosurgical, Cutting & Coagulation & Accessories

MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED

The following data is part of a premarket notification filed by Modern Medical Equipment Manufacturing Limited with the FDA for Disposable Laparoscopic Electrode, Disposable Laparoscopic Electrode.

Pre-market Notification Details

Device IDK134006
510k NumberK134006
Device Name:DISPOSABLE LAPAROSCOPIC ELECTRODE, DISPOSABLE LAPAROSCOPIC ELECTRODE
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED 35-41 TAI LIN PAI ROAD, 5F GOLD KING INDUSTRIAL BUILDING KWAI CHUNG Hong Kong,  CN Ch
ContactThomas Chan Tsz Fung
CorrespondentThomas Chan Tsz Fung
MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED 35-41 TAI LIN PAI ROAD, 5F GOLD KING INDUSTRIAL BUILDING KWAI CHUNG Hong Kong,  CN Ch
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-27
Decision Date2014-11-21
Summary:summary

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